{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["The invention provides a method and system for cleaning pet paws providing a bounded container containing a plurality of soft scrub brushes defining a paw cleaning region within an outer container wall wherein cleaning solution can flow freely within the container between a paw-for-cleaning, the container wall, and the brushes while allowing space for sediment. A spill resistant lid allows easy transport. An optional splash resistant lid containing a further brush boundary enables an enhanced side leg cleaning. The proposed method and system enables an enhanced deep cleaning through repeated submersion within the container and removable of debris. The system aids in prevention of infection and disease."], "input": "CROSS REFERENCE TO RELATED APPLICATIONS \n       [0001]    This application relates to and claims priority from U.S. Ser. No. 61/819,547 filed May 4, 2013, the entire contents of which are incorporated herein by reference. \n     \n    \n     FIGURE FOR PUBLICATION \n       [0002]    \n       FIG. 1 \n     \n       BACKGROUND OF THE INVENTION \n       [0003]    1. Field of the Invention \n         [0004]    The present invention relates to a method and system for cleaning pet paws or other animal appendages including feet, hooves, ears, tails, and limbs. More particularly, the present invention provides a method and system for cleaning pet appendages that is readily transported and stored between uses, readily adapts to specific uses, and enables rapid and effective appendage cleaning but may be readily cleaned and sealed between uses. \n         [0005]    2. Description of the Related Art \n         [0006]    Conventional pet foot cleaning devices are generally known from simple washings in a tub or basin using soapy water and optionally with the use of hand-agitation. Over time more complex, and expensive, devices have been developed. \n         [0007]    One such complex device is a grooming and cleaning scissor action device using a pair of opposed semi-circular brushes, as seen in U.S. Pat. No. 7,258,078 (Maiello), the contents of which are incorporated herein by reference. In use, the brushes are placed about a base of an animal tail, limb, or paw, and squeezed together applying pressure to the animal appendage. It is envisioned, that in cleaning such an animal would be outside, or standing in a tub able to receive any removed debris. Unfortunately, there is no ability to transport the cleaning device convenient with cleaning solution, and the device is not convenient to all forms of appendage. In use, the device is more for show-grooming to fluff-hair than for real cleaning. The device cannot be easily transported post-use or sterilized. \n         [0008]    Another difficult device is a paw sucker as shown in U.S. Pat. No. 7,654,228 (Graham), the entire contents of which are incorporated herein by reference, where an extensive spray and suction device (operating with a suction motor) is placed about a paw and agitated. A complex discharge hose and separate waste canister are employed requiring extensive costs and difficulty. \n         [0009]    A different product tube is provided with a splash guard in U.S. Pat. No. 8,371,247 (Flemming), the entire contents of which are incorporated herein by reference, wherein a sort of elastic sock is placed about a curved frustoconical tube. During use, an animals foot is thrust within, but lacking any retaining or sealing feature, the sock is readily released from the tube and be retained on a paw or foot, easily spilling any solution in the frustoconical tube, and being otherwise non-usable for transport and easy steralization. \n         [0010]    In an unrelated human pre-operative surgical cleaning device U.S. Pat. No. 4,181,446 (Kaufman), the entire contents of which are incorporated herein by reference, a flexible surgical scrubber brush is provided that has bristles on one side and a rubbing pad or sponge on a back side thereof. In cleaning a human patient or medical device, extensive user-hand manipulation bends and flexes the brush and forces the bristles of the brush into finger joints. \n       ASPECTS AND SUMMARY OF THE INVENTION \n       [0011]    In response, it is now recognized that there is a need for an improved paw cleaning method and system that addresses at least one of the concerns noted. \n         [0012]    In another aspect of the present invention, there is a method and system provided to reduce or eliminate the transmission of bacteria, parasites, fungus, toxins, contaminants, irritants, chemicals, and waste products found on roads, sidewalks, parks into user&#39;s homes, automobiles, or other locations where cleanliness is desired. \n         [0013]    In one aspect of the present invention, there is provided a method and system for cleaning pet limbs, particularly feet, providing a bounded container containing a plurality of soft scrub brushes defining a paw cleaning region within an outer container wall wherein cleaning solution can flow freely within the container between a paw-for-cleaning, the container wall, and the brushes while allowing space for sediment. \n         [0014]    Another alternative aspect of the present invention provides a sealing spill resistant lid for sealing the container between uses for easy transport and containing any fresh cleaning solution, or transporting any post-cleaning debris prior to disposal. \n         [0015]    In another alternative aspect of the present invention a splash resistant lid contains a further brush boundary feature enabling an enhanced side limb or leg cleaning during use. \n         [0016]    In another alternative aspect of the present invention, the proposed method and system enables an enhanced deep cleaning through repeated submersion within the container and removable of debris. The system aids in prevention of infection and disease. \n         [0017]    It is another alternative aspect of the present invention, wherein, the brush elements may be provided in a fixed form or in an optional removable-replaceable form. For example, a separate removable brush-holding cradle, or even a removable brush, may be used or slots or retainer structures may be formed directly into the container wall to removable-receive brushes or a brush-holding cradle. The brushes, in such brush-holding cradle or the slots or retaining structures, may be recycled (but cleaned or not yet used) brushes. Such brushes may be sourced, for example, from the surgical procedure brushes (approximately 1-5 million used annually) many of which are \u2018used\u2019 in a medial sense (not sterile) and must be discarded for safety, but which are fully-clean and ready for use in a practical animal-cleaning process. For example, a brush package (noted below) may be opened-for-surgical-use, but never actually used\u2014such a brush is fully clean but cannot be re-packaged and must be thrown away, and could be recycled for use in the present invention. In another example, such brushes may have an \u2018expiration\u2019 or \u2018use by\u2019 date on such packaging when made in mass, and non-use prior to the date prevents use on a human patient. The present invention promotes recycling by providing a system to use such devices. \n         [0018]    The above and other aspects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawings, in which like reference numerals designate the same elements. \n     \n    \n     \n       BRIEF DESCRIPTION OF THE DRAWINGS \n         [0019]      FIG. 1A  is an illustrative view of the proposed system relative to a paw to be cleaned. \n           [0020]      FIG. 1B  is an illustrative view of the proposed system with a paw inserted for cleaning. \n           [0021]      FIG. 2  is a perspective view of the proposed system with a cleaning cover installed for use. \n           [0022]      FIG. 3  is an exploded view of  FIG. 2  with an alternative sealing lid optionally provided for the container. \n           [0023]      FIG. 4  is a sectional view along Section  4 - 4  in  FIG. 2 . \n           [0024]      FIG. 4A  is a sectional view along section  4 A- 4 A in  FIG. 4 . \n           [0025]      FIG. 5  is a top plan view of an alternative sectional through a container as in  FIG. 1A , shown with three brush elements. \n           [0026]      FIG. 6  is a top plan view of another alternative section through a container as shown in  FIG. 1A , shown with five brush elements. \n       \n    \n    \n     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS \n       [0027]    Reference will now be made in detail to embodiments of the invention. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps. The drawings are in simplified form and are not to precise scale. The word \u2018couple\u2019 and similar terms do not necessarily denote direct and immediate connections, but also include connections through intermediate elements or devices. For purposes of convenience and clarity only, directional (up/down, etc.) or motional (forward/back, etc.) terms may be used with respect to the drawings. These and similar directional terms should not be construed to limit the scope in any manner. It will also be understood that other embodiments may be utilized without departing from the scope of the present invention, and that the detailed description is not to be taken in a limiting sense, and that elements may be differently positioned, or otherwise noted as in the appended claims without requirements of the written description being required thereto. \n         [0028]    Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments of the present invention; however, the order of description should not be construed to imply that these operations are order dependent. \n         [0029]    Referring now to  FIGS. 1A and 1B , a proposed cleaning system  1  is provided with a container  2  for retaining, and optionally removably retaining one or more brushes  8  relative to an animal limb  5  (a paw is shown) to be cleaned. Container  2  includes threads  7  about an outer upper surface thereof for removable engagement with a cleaning cover  3 , or a sealing lid or cover  4 , as will be discussed. During a use, limb  5  is thrust within container  2  and agitated with bristles  8 B of brushes  8  for removal of debris and detritus. Additional solutions may be added, including water, detergent, and other types, without departing from the scope and sprit of the present invention. \n         [0030]    Additionally referring now to  FIGS. 2 and 3 , wherein system  1  is provided with a threadably secured cleaning cover  3  having a cleaning opening  3 A for receiving limb  5  therein. As shown in  FIGS. 2 and 3 , the inner surface of cleaning opening  3 A additionally contains a brush element  8  with bristles  8 B facing inwardly. Additionally, in  FIG. 3 , sealing lid  4  is provided having an interior threading section  7  (as shown) which may threadably engage an additional outer threaded section on the outer surface of cleaning lid  3 , see  FIG. 3  for this version. As will be appreciated in  FIG. 3 , an entire system  1  may be modified to have, in combination container  2 , cleaning lid  3 , and sealing lid  4 , or (as shown in  FIG. 2 ) system  1  may including container  2  and cleaning lid  3 , without a cover. \n         [0031]    In either case, cleaning cover  3  may be readily modified to have threads  7 , on an inner or outer surface, or both, without departing from the scope and spirit of the present invention. Additionally, it will be noted that threads  7  may be replaced with sealing tabs (not shown) sealing frictio-rings (like a sealing lid), or any other type of engagement system to secure cover  3  or lid  4  to container  2 , without departing from the scope and spirit of the present invention. \n         [0032]    Additionally referring now to  FIGS. 4 and 4A , wherein a cross section and top-section view are provided of a system  1 , engaged and containing solution  6 , which may be any suitable fluid component, or combination of components for washing, sterilizing, etc. and may contain antimicrobial, antibiotic, anti-fungal, or other curative and assistive components, and solutions within the scope of the present invention. For example, medical treatment components may be added to solution  6 . \n         [0033]    As will be appreciated each brush  8  contains a brush base SA that spaces the respective brush  8 , having bristles  8 B from the outer container  2 . Base  8 A contains flow openings  8 C both on a side leg region and a base region supporting bristles  8 B. It will therefore be recognized by those of skill in the art having studied the present invention, that solution  6  may flow readily between bristles  8 B, base  8 A, flow holes  8 C and brush  8  during a use, and may slosh throughout system  1  to aid in treating, cleaning, rinsing, or contacting an animal limb  5  during a use. See for example the flow arrows noted in  FIGS. 4 and 4A . It will also be understood, that solution  6  may be of any level in system  1 . It will also be understood that any debris or detritus removed from an animal limb  5  during use, may remain within container  2  post-use, so as to allow for easy removal and rinsing-out by removal of cleaning cover  3 . \n         [0034]    It will additionally be understood, that the proposed system  1  may function suitably without a cleaning cover  3  (as is shown in  FIGS. 1A ,  1 B. For example, where an especially large animal limb  5  is used, cover  3  may be unduly restricting, and may be removed. \n         [0035]    Referring now to  FIGS. 5 and 6 , it will be noted that instead of a roundish, brush  8  (central brush  8  shown in  FIGS. 2-4A , several component member brushes  8  may be used for similar effects without departing from the scope and spirit of the present invention. For example, as seen in  FIG. 5 , four brushes  8  may be arranged (one on the bottom and three in triangle form). For another example, as seen in  FIG. 6 , six brushes  8  may be arranged (one on the bottom and five in pentagon form). In the examples in  FIGS. 5 and 6 , it will be understood, that a plurality of brushes  8 , or a continuous brush  8 , may be used without departing from the scope and spirit of the present invention. \n         [0036]    In an alternative embodiment regarding  FIGS. 2 and 3 , it will be understood that side and bottom brushes  8  maybe formed as a single integral unit, that is slidably removable from within container  2  without departing from the scope and spirit of the present invention. For example, a unitary replacement brush unit (not shown) may be slidable removable in and out of container  2  within the scope of the present invention. Additionally, a further example would involve a brush-carrier unit (not shown), wherein a plurality individual brushes  8  (linear, arc shaped or otherwise) may be removably retained in a brush-carrier unit (not shown) that is slid within container  2  for holding replacement brushes. \n         [0037]    In one aspect of the present invention, surgical scrub brushes are employed in the container and cleaning lid derived from Scrub Care\u00ae which is a surgical scrub brush-sponge/nail cleaning mixed with Exidine\u00ae4 a type of germicidal solution; Allegiance Heathcare Corporation, McGaw Park, Ill. 60085 US, (NDC 63517-007-25). In this use, the surgical brushes are constructed from a suitable plastic (polyethylene (PE), high density PE (HDPE), medium density PE (MDPE), low density PE (LDPE), or any other type of plastic suitable for the purposes intended. Additionally, the brushes are not limited to plastic, but may be constructed from suitable natural materials, including but not limited to, fibers, hair, bristles, and any other type of natural brush-like fiber that would be suitable for the purposes intended. Additionally, a brush may be constructed from a combination of materials without departing from the scope and spirit of the present invention. For example, a brush backing may be of plastic and bristles may be boar-hair or other natural material, and vice-versa. \n         [0038]    It is another alternative aspect of the present invention, that a the brush construction/bristle construction shown within the container may be formed in alternative shapes without departing from the scope and spirit of the present invention. For example, a continuous bounding surface of bristles may be provided (e.g., a circular bristle surface), or any other related shape. Additionally, a brush may be removed from a floor/bottom surface of the container as a modification thereof. Additionally, a brush-holding cradle may be inserted into the container, so that the brush-holding cradle may be removed from the container (the brushes not being fixed to the container wall, but fixed to a brush-holding cradle (noted but not shown). As a result, it will be apparent to those of skill in the art having studied the present disclosure that the method and system may be modified without departing from the scope and spirit of the present invention. \n         [0039]    It will also be understood, that as used herein the device may be used with any cleaning solution, soap, detergent, germicidal or antiseptic for dispersion or surface scrubbing known within the surgical or veterinarian arts without departing from the scope and spirit of the present invention. \n         [0040]    It will be understood that the present invention relates to a method and system for cleaning pet paws or other animal appendages including feet, hooves, and limbs. It will be understood that a dog-paw may be conveniently used, but also conveniently a sheep hoof may be cleaned, or a rabbit foot\u2014all with differing shapes and needs for cleaning, but all ready cleaned by adaptive us of the present device. Therefore, it will be recognized by one of skill in the art having studied the present disclosure, that the present device using a plurality of flow-through type brushes may be easily used to clean a range of animals. For example, cleaning sheep hooves for serious medical treatment or disease prevention or cleaning a pet-dog foot following a simple walk during a winter or muddy day. More particularly, the present invention provides a method and system for cleaning pet appendages that is readily transported and stored between uses, readily adapts to specific uses, and environments proximate that treatment surface is not limited. \n         [0041]    Having described at least one of the preferred embodiments of the present invention with reference to the accompanying drawings, it will be apparent to those skills that the invention is not limited to those precise embodiments, and that various modifications and variations can be made in the presently disclosed system without departing from the scope or spirit of the invention. Thus, it is intended that the present disclosure cover modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["The invention comprises a process for preparing oatmeal, which process comprises soaking steel cut oats and oat bran for a period of time sufficient to hydrate the oats, mixing rolled oats into the hydrated oat fraction, cooking the resultant mixture for a period of time sufficient to produce a flavorful food product, and optionally aseptically packaging the resulting product. The invention also comprises a process for preparing an oatmeal composition, which process comprises cooking steel cut oats in a manner so that the material is hydrated, adding rolled oats after a cooking time such that cooking of steel cut oats is substantially complete, adding optionally hydrated oat bran either before or after addition of the rolled oats, cooking the entire mixture for a time sufficient to render the product edible and packaging the product. The packaging steps in this aspect of the invention may comprise adding an acidic modifier to the cookable oat mixture, filling containers with the cooked oat mixture, inverting the filled containers allowing hot air to rise through the containers, and cooling the oatmeal. Alternatively, the packaging steps may comprise transferring the product to containers and cooling the product and container to a temperature sufficiently low so as to maintain product freshness and to retard spoilage."], "input": "FIELD OF THE INVENTION \n     The invention relates to an oatmeal food product that is optionally packaged aseptically and can be heated with microwave cooking and a process of making same. \n     BACKGROUND OF THE INVENTION \n     Oatmeal compositions have been known for a long period of time. More recently, oatmeal food products have become available in prepackaged forms. Usually these products are in a dry form which need water for cooking. Packaging of oatmeal in water-containing form so that nothing need be added before consumer preparation has not been used due to the adverse effects such processing has on the flavor and texture of the resulting oatmeal product. Packaging oatmeal preparations with water can result in the final product in oat particles that have degraded to a form of thick paste which lacks texture. \n     It would be desirable to have a complete oatmeal food product that could be prepared without the addition of water or other ingredients, and which may be stored in prepackaged form for long periods of time. \n     SUMMARY OF THE INVENTION \n     It is an object of the invention to provide an optionally aseptically prepared oatmeal based food composition that retains a pleasing texture. \n     It is another object of the invention to provide processes for optionally aseptically preparing an oatmeal based food composition that retains a pleasing texture. \n     In accordance with these and other objects which will become apparent from the description below, one such process comprises: \n     soaking steel cut oats and oat bran for a period of time sufficient to hydrate said steel cut oats and said oat bran and form a hydrated oat mixture; \n     adding rolled oats as a dry feed to the hydrated oat mixture to form a cookable oat mixture; \n     heating the cookable oat mixture for a period of time sufficient to cook the cookable oat mixture; and \n     optionally aseptically packaging the cooked oat mixture. \n     Alternatively, the preparation may be carried out in a retort apparatus, e.g., an open kettle, with additional cooking taking place after filling but before sealing of the containers. In the retort preparation, water, steel-out oats, oat bran and flavorings are combined, heated to a temperature sufficient to effect cooking, rolled oats are added, and the entire mixture is simmered for a time sufficient to allow particulates to settle. The mixture is then placed in containers and cooking is completed. The containers are then sealed and may be heated to sanitize the product. \n     The process according to that invention results in a pleasing oatmeal food that can be used economically with or without additional flavoring agents by domestic and commercial food preparers. \n     The present invention is further directed to additional methods of packaging of an oatmeal composition with water so that pleasing taste and texture are retained. These processes according to the present invention comprise: \n     cooking steel cut oats and oat bran in a manner so that the material is hydrated and substantially cooked, \n     adding rolled oats at a point in the process where cooking of the steel cut oats and oat bran is substantially complete, \n     cooking the entire mixture for a time sufficient to render the product edible, and \n     packaging the product and its associated water by a &#34;hot-fill&#34; or a &#34;fresh-pack&#34; process. \n     In the &#34;fresh pack&#34; process, the product is placed in containers designed for shipment and sale of the product to purchasers, e.g., large buckets or individual packets or bowls. After packing with the freshly cooked, hot product, the product and container are chilled to a temperature sufficient to maintain freshness and are maintained at temperature until use. \n     In the &#34;hot fill&#34; process, the product is packed hot into containers, inverted so hot air present rises to the top, and the containers are sealed, resulting in a sterile package. \n     DETAILED DESCRIPTION OF THE INVENTION \n     Steel cut oats are well known in the industry as oat particulates produced by cutting whole groats from clean, sound oats without rolling. A preferred form of steel cut oat is commercially known as a &#34;table steel cut oat groat&#34;. A desirable granulation size is about 8% by weight maximum over a U.S. #7 sieve and 25% maximum through a U.S. #12 sieve. Steel cut oats are used in the invention to add texture to the resulting food product. \n     Oat bran is water soluble and should be handled in such a manner as to avoid clumping. Mild agitation is preferred to break up any clumps that may have formed yet avoid harm to the added oat bran. It is not desirable to have a high rate of agitation as the oat bran will break up and solubilize to the detriment of the resulting flavor. \n     Any coarseness or granulation of oat bran can be used depending on the taste and texture desired in the final product. A preferred granulation has 10% maximum on U.S. #10, 55-75% on U.S. #20, 10-30% on U.S. #30, and 10% maximum in the pan at an overall density of about 30-32 lb/cu.ft. \n     Rolled oats come in a variety of commercially available thicknesses. All of these thicknesses are useful in the process according to the invention. Rolled oats are available as &#34;thick table rolled&#34;, &#34;regular rolled&#34;, and &#34;quick cooking oats&#34; in order of decreasing thickness. The thick rolled oats are preferred as they retain their texture and overall flavorful contribution while being less susceptible to processing damage. A desirable granulation of thick table rolled oats is about 80% minimum on a U.S. #8 sieve and 10% maximum passing through a U.S. #20 sieve. \n     In the method for optionally &#34;aseptically&#34; processing oats and oat fractions into a flavorful oatmeal composition, the first step is to hydrate steel cut oats, for example, by soaking in water for up to about 45 minutes at about 65-85\u00b0 F. Steel cut oats are well known in the industry as oat particulates produced by cutting whole groats from clean, sound oats without rolling. A preferred form of steel cut oat is commercially known as a &#34;table steel cut oat groat&#34;. A desirable granulation size is about 8% by weight maximum over a U.S. #7 sieve and 25% maximum through a U.S. #12 sieve. Steel cut oats are used in the invention to add texture to the resulting food product. \n     To the soaking steel cut oats can be added an optional flavor fraction. A wide variety of flavors agents may be present but preferably comprise cinnamon, honey or other sweetening material, salt, and vanilla in proportions to taste. Cinnamon is desirably present in virtually any physical form at a weight ratio with respect to the overall composition of about 0.2 to 0.6%, while honey is desirably added in a weight ratio of about 4 to 12%. Salt can be used in a weight ratio of up to about 0.26% depending on flavor and dietary considerations for the product. Vanilla can be added in a weight ratio of 0.4 to 1.2%, depending on the vanilla flavor concentration (fold). \n     It should be understood that the flavor fraction may contain other ingredients or use widely different proportions for the listed components. Taste, style, and economic factors will tend to guide the formulation of the flavor fraction if added to the product at all. \n     Oat bran is preferably added to the hydrating steel cut oats after the cut oats have been soaking for about 7 to 12 minutes. Oat bran is water soluble and should be added in such a manner as to avoid clumping. Mild agitation is preferred to break up any clumps that may have formed yet avoid harm to the added oat bran. It is not desirable to have a high rate of agitation as the oat bran will break up and solubilize to the detriment of the resulting flavor. \n     Any coarseness or granulation of oat bran can be used depending on the taste and texture desired in the final product. A preferred granulation has 10% maximum on U.S. #10, 55-75% on U.S. #20, 10-30% on U.S. #30, and 10% maximum in the pan at an overall density of about 30-32 lb/cu. ft. \n     When the steel cut oats and oat bran have been mixed and soaked, the cut oat/bran mixture is desirably transferred to a holding reservoir. This transfer step may be through a series of pipes or other handling apparatus. The rate and amount of shear that is induced is desirably minimized to preserve the texture of the steel cut oats and the oat bran while assuring adequate mixing to avoid clumping. \n     Rolled oats (otherwise known as oat flakes) can be added at any point in the process before cooking the mixture. Desirably, they are added to the cut oat/bran mixture in the holding reservoir. The rolled oats are even more preferably added before the cut oat/bran mix is passed to the reservoir to minimize shear forces on the flakes and thereby preserve their texture. \n     The oat mixture containing cut oats, bran, and flakes is then heated to a temperature of about 250\u00b0 to 325\u00b0 F. for a time sufficient to cook the oatmeal fractions, e.g. for 15 seconds to about 2 minutes, depending on the temperature. It is preferable to maintain aseptic conditions during the cooking and avoid the introduction of any microorganisms or bacteria which could adversely affect the food product. For that reason, conventional aseptic processing equipment such as closed kettles and heating tubes are desirably used. This aseptic product has a shelf like under refrigeration at 40\u00b0-50\u00b0 F. of about 4-6 months. \n     If the storage conditions of the aseptically packaged product are likely to be at temperatures above 75\u00b0 F. for an extended period of time, it may be desirable to add a small quantity of preservative to ensure the safety of the food composition. Among the well known, suitable preservatives are potassium sorbate and sodium benzoate. \n     Further, where aseptic packaging conditions are not used, conventional preservatives may be added according to conventional protocols as is customary in the industry to preserve product freshness. \n     In the retort preparation, the steel cut oats and oat bran mixture is heated to a temperature of about 150 \u00b0 F. to about 220\u00b0 F., preferably at least 180\u00b0 F. The rolled oats are then added, and the entire mixture is simmered for about 2 to 5 minutes. Preferably, the mixture is simmered for about 3 minutes. The mixture is subsequently placed into containers such as bowls or pouches designed as retail or wholesale packaging for the product and additionally cooked for a time sufficient to produce an edible composition. \n     Cooking time in the containers is affected by container size and thickness, with larger and/or denser containers requiring longer cooking times. Preferred cooking time in containers is about 13 minutes to 1 hour and 25 minutes. Preferred cooking temperature is at least about 250\u00b0 F., more preferably 250\u00b0 to about 310\u00b0 F. Further, rotation of the container may be performed, which rotation further shortens cooking time. Rotation of the containers of up to 15 rpm may be used. \n     Flavorings may be added, as discussed above. In addition, raisins may be included in the composition at any point in the preparation. Where raisins are to be added, they are preferably added in the final stages of the procedure. \n     When cooking is complete, the containers are sealed and may be heated to sanitize the contents. Alternatively, conventional preservatives may be added. \n     In both the optional aseptic and retort processes above, it is desirable to add the rolled oats at a point in the preparation so that their processing is minimized, in order to avoid production of a paste-like product. Although the specific order of the steps discussed above represents the preferred methods of practicing the invention, other variations which would delay processing of the rolled oats are also intended to be encompassed within the invention. For example, the steel-cut oats may be cooked separately, combined with previously hydrated oat bran, and then cooked with rolled oats for a short time. \n     In the &#34;hot fill&#34; and &#34;fresh pack&#34; processes, when the steel cut oats and oat bran have been mixed and soaked, the cut oat/bran mixture may be transferred to a holding reservoir or cooking apparatus, e.g., an open kettle. This transfer step may be through a series of pipes or other handling apparatus. The rate and amount of shear that is induced is desirably minimized to preserve the texture of the steel cut oats and the oat bran while assuring adequate mixing to avoid clumping. \n     Rolled oats (otherwise known as oat flakes) are added to the cut oat/bran mixture in the cooking apparatus. The rolled oats are even more preferably added before the cut oat/bran mix is passed to the reservoir, where a reservoir is used, to minimize shear forces on the flakes and thereby preserve their texture. In both the hot-fill and fresh pack processes, it is desirable to add the rolled oats at a point in the preparation so that their processing is minimized, in order to avoid production of a paste-like product. Although the specific order of the processing steps discussed below represents the preferred method of practicing the invention, other variations which would delay processing of the rolled oats are also intended to be encompassed within the invention. For example, the steel-cut oats may be first hydrated, combined with the oat bran, and then cooked, with subsequent addition of rolled oats and optionally further cooking for a short time. \n     In a preferred embodiment of the fresh pack process, the steel cut oats and water are cooked at a rolling boil for about 5 to 15 minutes, preferably about 10 minutes, at about 15-18 psi. The rolled oats are then added and the mixture is cooked for an additional approximately 3 to 8 minutes. The oat bran is then added and cooking is continued for up to about 3 minutes. Preferably, the bran is previously hydrated to shorten cooking time, e.g., soaked for about 1 to 5 minutes in hot water. The mixture is then transferred to containers, e.g., through a pump system and chilled to about 40\u00b0 to 85\u00b0 F., preferably to approximately 50\u00b0 to 80\u00b0 F. The container and oatmeal may be cooled using a variety of conventional container cooling techniques, e.g., contact with cold water or gas, refrigeration, etc. \n     Depending on the desired end use of the product, the containers may be large pails for food service applications or retail packs for consumer use. Where such packaging is not sterile, preservatives are added, generally to the cooking apparatus during processing. Among the well known, suitable preservatives are potassium sorbate and sodium benzoate. These and other conventional preservatives may be added according to conventional protocols as is customary in the industry to preserve product freshness. \n     In a preferred embodiment of the hot fill technique, the oatmeal composition can be acidified with suitable pH modifier using an open kettle for the cooking. Suitable pH modifiers include glucono delta lactone, apple butter, apple pectin, any naturally acidic flavorings, and combinations thereof. The resulting product can then be filled into containers at an elevated temperature, e.g., about 140\u00b0 to 160\u00b0 F., sealed with a removable plastic film, and inverted. Preferably, the container is hot filled with about 80-98 vol. % oatmeal with the remainder being air that is naturally drawn into the container during the filling step and becomes heated to the oatmeal temperature. An inversion step permits hot air within the container to rise through the oatmeal composition and kill any bacteria that might have been introduced as a result of the open kettle cooking. The result of the inversion is a sterile package. \n     The hot fill product according to the invention has a refrigerated shelf life of approximately 4-6 months for a 24 ounce container. The product can be opened and heated on a conventional stove or in a microwave oven set at high for about 45 to 90 seconds depending on the oven power. Additional flavoring agents may be added to the cooked product if desired. \n     In either process, an optional flavor fraction may be added during processing, preferably to the steel cut oats. A wide variety of flavors agents may be present but preferably comprise cinnamon, honey or other sweetening material, salt, and vanilla in proportions to taste. Cinnamon is desirably present in virtually any physical form at a weight ratio with respect to the overall composition of about 0.2 to 0.6%, while honey is desirably added in a weight ratio of about 4 to 12%. Salt can be used in a weight ratio of up to about 0.26% depending on flavor and dietary considerations for the product. Vanilla can be added in a weight ratio of 0.4 to 1.2%, depending on the vanilla flavor concentration (fold). \n     It should be understood that the flavor fraction may contain other ingredients or use widely different proportions for the listed components. Taste, style, and economic factors will tend to guide the formulation of the flavor fraction if added to the product at all. In addition, raisins may be included in the composition at any point in the preparation. Where raisins are to be added, they are preferably added in the final stages of the procedure. \n     Without further elaboration, it is believed that one skilled in the art can, using the preceding description, utilize the present invention to its fullest extent. The following preferred specific embodiments are, therefore, to be construed as merely illustrative, and not limitative, of the remainder of the disclosure in any way whatsoever. \n     The entire texts of all applications, patents and publications, if any, cited above and below, are hereby incorporated by reference. \n    \n    \n     EXAMPLES \n     EXAMPLE 1 \n     \n                       TABLE 1______________________________________Ingredient             Wt. %______________________________________Water                  73.9Steel cut oat groats   8.0Thick rolled oats      8.0Wildflower honey       8.0Oat Bran               0.76McCormick Vanilla Extract (v-401)                  0.7Ground cinnamon        0.4Salt                   0.24______________________________________ \n    \n     To prepare the oatmeal composition as shown in Table 1, the following process was used: \n     In a kettle, warm water at 70\u00b0 F. was mixed with steel cut oats and soaked for a total time of 30 minutes. During the soaking, a flavor fraction of water, honey, vanilla, salt, and cinnamon was dissolved in the water. Oat bran was added to the soaking cut oat/flavor mixture with mild agitation. \n     Rolled oats were then added as a dry feed at the rate of 2.1 lbs/min. When mixed, the oatmeal composition was passed through a cooking tube of 130 inches long at 276\u00b0 F. at the rate of 3 gallons per minute. The cooked mixture was filled into six ounce plastic cups at 110\u00b0 to 120\u00b0 F. and capped. \n     EXAMPLE 2 \n     Water was brought to a rolling boil, and a honey container was placed into the hot water bath and set aside to loosen up. Two gallons of water was removed to hydrate the oat bran, blended with the bran until smooth and until no lumps existed, set aside and covered with a plastic bag to retain heat. Preservatives were added directly to the water in the kettle and stirred to dissolve. Salt, vanilla and cinnamon were added while stirring constantly. \n     Steel-cut oats were added, cooked for 10 minutes at an even, rolling boil throughout cooking (approximately 15-18 PSI or 210\u00b0-212\u00b0 F.). At 10 minutes, rolled oats were added and cooked for an additional 6 minutes. At 16 minutes, the hydrated oat bran, honey (and raisins) were added and cooked for an additional 3 minutes. \n     Steam was shut off immediately and as quickly as possible the product was bucketed out into large pails, followed immediately by CO 2  chilling to 50\u00b0-85\u00b0. CO 2  time: Approximately 2 minutes 35 seconds. \n     EXAMPLE 3 \n     \n                       TABLE 2______________________________________                            Percentage ofIngredients   Description     Quantity Ingredient______________________________________Water   Potable         10509.5  77.23Oats    Conagra Steel Cut                   1088.6   8.00   (Code 8273)Honey   Wild Flower (TM.sub.2)                   680.4    5.00Vanilla Gold Medal-Borden                   81.6     0.60Salt    Non-Iodized     21.8     0.16Cinnamon   McCormick (TM.sub.2)                   34.0     0.25Oat Bran   Mothers (Code 8L1J)                   103.4    0.76Oats    Conagra #3 Rolled                   1086.6   8.00   (Code 8273)                   13607.9  100.00______________________________________ \n    \n     PROCEDURE \n     1. Combine all ingredients (except rolled oats) to maintain identity. Heat to 180\u00b0 F. \n     2. Add rolled oats, simmer 3 minutes. Turn off heat. \n     3. Remove product from kettle. \n     4. Record yield 28 lbs. Correct to 100% yield 30 lbs. \n     5. Fill bowls and pouches to 8.0 ounces. \n     \n         ______________________________________Pouches           Bowls______________________________________Process Temperature - 250\u00b0 F.             Process Temperature - 250\u00b0 F.Rotations/Minute - 9 RPM             Rotations/Minute - 0Processing Pressure - 30 psi             Processing Pressure - 30 psiTotal Cook Time - 13 minutes             Total Cook Time - 26 minutes______________________________________ \n    \n     The preceding examples can be repeated with similar success by substituting the generically or specifically described reactants and/or operating conditions of this invention for those used in the preceding examples. \n     From the foregoing description, one skilled in the art can easily ascertain the essential characteristics of this invention and, without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["A log rolling apparatus includes a body having a depression or well positioned therein and a large sheet of canvas or similar flexible material positioned over the body and the well. The canvas is fixedly attached to respective ends of the body and a dual link pivotal member is provided to which is attached a roller movable between the body and the canvas. Sheets of flammable material and optionally other burnable material, such as leaves or the like, may be placed within the well over the top surface of the canvas, and the pivotal member may then be rotated about the body in a manner which causes the canvas to attempt to follow the roller attached to the member, thus causing the top surface of the canvas to slide against itself so as to roll up the flammable sheet material into a log shape with the leaves, if used, enclosed by the sheet material."], "input": "BACKGROUND OF THE INVENTION \n     1. Field of the Invention \n     The present invention relates to devices for rolling sheet materials and particulate burnable material, such as leaves or the like, into tubular shapes, and more particularly pertains to a log rolling apparatus which permits sheets of flammable material, such as newspapers or the like, to be rolled into log shapes so as to facilitate a burning thereof. \n     2. Description of the Prior Art \n     It is generally well known to take sheets of flammable material, such as newspapers or the like, and to roll the same into compact, tight log shapes for the purpose of burning them in fireplaces. For example, U.S. Pat. No. 3,958,499, issued to P. Albee, Jr. on May 25, 1976, illustrates a newspaper log maker which effectively consists of a pair of vertical standards having circular bearings at their upper ends, and a main shaft positioned between the bearings and rotatable in response to a crank arm attached thereto. A clamp bar is formed as a portion of the main shaft so that an edge of a newspaper may be clamped thereto, and the shaft may then be rotated manually through the use of the crank arm, so as to roll a plurality of newspapers into a log shape. While this construction does facilitate the manufacture of newspaper logs, it inherently possesses the disadvantage of not being able to roll logs which include the use of flammable materials that are not in sheet form. Further, the Albee, Jr. device requires a disassembly thereof each time a log is rolled, since it is necessary to remove the main shaft so that the newspaper log can be removed therefrom. \n     Similarly, U.S. Pat. No. 4,039,299, issued to C. Porter et al on Aug. 2, 1977, discloses a device for the manufacture of paper fire logs which includes the use of a shallow open top tank having a liquid contained therein and an axially slotted shaft removably positioned between opposed walls of the tank. Sheets of paper may be directed into the axial slot of the shaft and the same may then be rotated so as to draw the paper through the liquid and around the shaft into a log shape. Further, the Porter et al device employs both manual and powered rotation means for the shaft and, as with Albee, Jr., the shaft must be removed from the apparatus in order to remove a paper fire log therefrom. Additionally, the construction of the Porter et al device only permits a winding of sheet material upon the rotatable shaft and no means are provided for winding materials thereon which are not of a sheet-like construction. As such, there still exists a need for manufacturing fire logs in a manner which includes the use of non-sheet-like flammable material in combination with flammable sheets. \n     SUMMARY OF THE INVENTION \n     The general purpose of the present invention, which will be subsequently described in greater detail, is to provide a log rolling apparatus that has all of the advantages of the priorly employed log rolling apparatuses and none of the disadvantages. To attain this, the present invention makes use of a curvilinearly-shaped body member having a depression or well portion formed therein and a sheet of canvas or similar material positioned completely over the body member and extending into the well, such sheet of material being fixedly attached at two opposed edges thereof in the position described. A pair of arms extend along the other two opposed sides of the body and are integrally attached together by a handle portion fixedly secured to remote ends of the arms. Further, the arms are of a multi-link construction and are pivotable about the body member along the sides thereof. Additionally, a roller is fixedly secured between the pair of arms at a position remote from and in substantial parallel alignment with the handle portion. In this respect, the roller lies between the body member and the canvas and is rotatable relative thereto in response to a pivotable movement of the arms along the sides of the body member. The multi-link construction of the arms permits an effective variation in their respective lengths, so as to facilitate movement of the roller along the body member at variable distances about the pivot points of the arms to the body. As such, it is not necessary that the roller be at a constant distance, i.e., radius, from its pivotable attachment points to the body member. Sheets of flammable material may be positioned within the well portion of the body member and then other flammable materials which are not in sheet form, such as leaves, corn fodder, and the like, may be deposited upon the flammable sheets prior to pivoting the arms along the sides of the body member. \n     As can be appreciated then, a pivotal movement of the arms along the sides of the body member results in the roller tending to pull the canvas away from the body member. However, due to the attachment of the canvas to respective ends of the body member, the canvas can only roll along across itself in a manner which results in the sheets of flammable material, along with the other flammable materials positioned thereon, being rolled into a log shape suitable for burning in a fireplace or the like. \n     It is therefore an object of the present invention to provide a log rolling apparatus which has all of the advantages of the priorly employed log rolling apparatuses and none of the disadvantages. \n     It is another object of the present invention to provide a log rolling apparatus which may be easily and economically manufactured. \n     It is a further object of the present invention to provide a log rolling apparatus which eliminates the need for a rotatable shaft about which flammable sheet-like materials are to be rolled. \n     Still another object of the present invention is to provide a log rolling apparatus which may be utilized to roll flammable materials which are not in sheet-like form into log shapes. \n     Yet another object of the present invention is to provide a log rolling apparatus which may be quickly operated to roll flammable materials into a log shape. \n     Even another object of the present invention is to provide a log rolling apparatus which is much simpler to operate than the log rolling apparatuses employed in the prior art. \n     These together with other objects and advantages which will become subsequently apparent reside in the details of construction and operation as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof, wherein like numerals refer to like parts throughout. \n    \n    \n     BRIEF DESCRIPTION OF THE DRAWINGS \n     FIG. 1 is a side elevational view of one embodiment of the log rolling apparatus forming the present invention. \n     FIG. 2 is a top plan view of the embodiment of the present invention illustrated in FIG. 1. \n     FIG. 3 is a transverse end view of the embodiment shown in FIG. 1. \n     FIG. 4 illustrates a second embodiment of the log rolling apparatus forming the present invention. \n    \n    \n     DESCRIPTION OF THE PREFERRED EMBODIMENTS \n     With reference now to the drawings and in particular to FIG. 1, a log rolling apparatus incorporating the principles and concepts of the present invention and generally designated by the reference numeral 10 will be discussed in detail. Specifically, FIG. 1 shows the log rolling apparatus 10 as including a body member 12 having a topmost curved surface 14 extending over a substantial portion of the body member, and further including a depression or well 16 formed therein as an integral part thereof. Further illustrated is the use of a sheet of canvas 18, or other flexible material, which is comformingly positioned in an overlying relationship across the body member 12 including the topmost curved surface 14 and the well 16. In this respect, the canvas 18 is fixedly secured to opposed ends 20, 22 of the body member 12 through the use of respective attachment means 24, 26. The attachment means 24, 26 are of a conventional construction and are designed to operate in a manner which permits the canvas sheet 18 to be adjusted in length, whereby the amount of canvas overlying the body member 12 can be controlled as desired. \n     Viewing FIGS. 1 and 2 together, it can be seen that the log rolling apparatus 10 further includes a rotation member 28 which is formed from a pair of first pivot arms 30, 32 pivotally attached to opposed sides 34, 36, respectively, of the body member 12 and second pivot arms 38, 40 respectively pivotally attached to the pivot arms 30, 32. Additionally, the second pivot arms 38, 40 are connected together through the use of a handle member 42 in the manner illustrated in FIG. 2. In this connection, it can be seen that the first pivot arms 30, 32 respectively pivot about pivot points 44, 46, while the second pivot arms 38, 40 are respectively pivotally attached to the first pivot arms at pivot points 48, 50. \n     As is further evident with reference to FIGS. 1-3, the rotation member 28 also includes a roller 52 which is normally positionable on a flat support surface 54 formed as a part of the body member 12 and which is rotatably attached between the second pivot arms 38, 40 in the manner most clearly illustrated in FIG. 2. In this connection, the roller 52 is rotatably positioned on a roller shaft 56 fixedly secured to the second pivot arms 38, 40, while spring 57 is provided which is attached between the body member 12 and the pivotable arm 30 so as to facilitate a return of the rotation member 28 to the position shown in FIG. 1. \n     As can be further ascertained with reference to FIGS. 1-3, the roller 52 is positioned on the log rolling apparatus 10 in a manner whereby it lies between the canvas 18 fixedly secured to the body member 12 and the uppermost surface of the body member 12 per se, to include the topmost curved surface 14 as well as the surface associated with the well 16. Also, clearly shown in FIGS. 2 and 3 is the fact that the canvas 18 extends substantially across the entire transverse width of the body member 12 so as to essentially entirely cover the roller 52, the well 16 and the topmost curved surface 14. \n     FIG. 4 has been provided to illustrate a second slightly modified embodiment of the present invention which differs only in the structural form of the body member 58. In this respect, the body member 58 functions in the same manner as the body member 12 illustrated in the embodiment of FIG. 1 with the exception that the topmost curved surface 14 of the FIG. 1 embodiment has been replaced by a topmost flat surface 60. To support this configuration, the well 62 has a first side portion 64 which is of a substantially greater length than a second side portion 66 associated with the other side of the well. This construction differs to some degree from the construction of FIG. 1 and accordingly, the embodiment of FIG. 4 can be operated by a user with somewhat less movement than that required by the first embodiment above described. As can be appreciated, the other elements associated with the log rolling apparatus 10 illustrated in FIG. 4 are essentially the same as those disclosed in the embodiment of FIG. 1, including a roller 52 positioned on a flat surface 54 and located between a canvas 18 fixedly secured to respective ends 20, 22 of the body member 58. Further, a rotation member 28 is provided which includes the use of the same first pivot arms 30, 32, as well as second pivot arms 38, 40. As such, the embodiments of FIGS. 1 and 4 are closely related in structure and are functionally operable in the exact same manner. \n     With respect to the operation of the present invention and with reference to FIG. 1, it can be seen that the log rolling apparatus should initially be provided with the rotation member 28 in the position illustrated, wherein the roller 52 is resting between the canvas 18 and the flat support surface 54. A user may then position a sheet of material 68, which typically might consist of a sheet of newspaper or the like, in the manner illustrated whereby the sheet 68 partially extends into the well portion 16, as well as overlying a portion of the topmost curved surface 14. As desired then, any type of flammable material 70 may be positioned in the well 16 so that the same fills a substantial portion of the well and partially overlies the sheet 68. At this point of the operation then, a user need only to grip the rotation member 28, preferably by the handle 42, and then rotate the same about the pivot point 44 in the manner indicated in phantom lines in FIG. 1. Specifically, it can be seen that a movement of the rotation member 28 to a first intermediate position 72, as shown in phantom lines, results in a rolling up of the sheet of material 68 due to the cross surface translational movement of the canvas 18 caused by the securing of the canvas to the body member 12 through use of attachment means 24. At this point, it can be appreciated that the roller 52 facilitates the movement of the rotation member 28 in the manner described since canvas portion 74, also indicated in phantom lines, increases in length during the rotational movement of the member 28, such increase in length being afforded by the canvas slidably rolling across the roller 52. As such, the canvas portions 76 and 78 lying proximate to the sheet material 68 move in opposite directions relative to one another so as to afford a rolling effect on the sheet. As can be further appreciated with reference to FIG. 1, the rolling of the sheet 68 into a cylindrical shape results in the flammable material 70 becoming permanently captured therein whereby a log 80 is created which is suitable for burning in a fireplace or the like. By the same token, it should noted that the multi-link construction of the arms of the rotation member 28 permits the distance between the shaft 56, which is the axis of rotation of the roller 52, and the arm pivot points 44, 46 to vary so as to accommodate the rolling movement of the roller over the surface 14 of the body member 12. In this respect, the multi-link construction permits the arm lengths to vary so that it is not necessary to construct the body member surface 14 in a perfectly circular shape, which would otherwise be required if the arm lengths were not variable. \n     Once the rotation member 28 as been rotated about the pivot point 44 to the position 82, also illustrated in phantom lines, it can be seen that the rolling operation has been completed so that the log 80 may be removed from the log rolling apparatus 10. The return spring 57 will then operate to assist the user in returning the rotation member 28 to the &#34;at rest&#34; position shown in FIG. 1, whereby a new sheet of material 68 may be inserted in the well 16 preparatory to making another log 80. Of course, the embodiment of FIG. 4 operates in essentially the same manner as that above described with reference to the embodiment of FIG. 1. In this regard, it can be seen that a rotation of the member 28 about the embodiment of FIG. 4 will create a similar log 80 once the member has been moved to the phantom position 84, and a continued rotation thereof will result in the log being positioned ready for removal on the topmost flat surface 60. \n     With respect to the above embodiments described, it can be understood that the optimum dimensional relationships for the parts of the invention are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the invention, subject only to limitations specifically appearing in the claims. In this connection, the types of materials as well as the structural configurations of the parts may take many different forms. For example, the present invention could be utilized to roll exclusively sheets of material into logs, such as logs which are constructed entirely of newspaper, while the flammable material 70 positionable within sheets 68 of newspapers or the like, might be wood chips, corn fodder, leaves, etc. Further, it can be appreciated that the sheets 68 might be formed from materials other than newspapers, such as cloth, plastics, etc. \n     The foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["A pet headgear comprises two halves operable in \u201cclamshell\u201d fashion to surround the head, nose and mouth of a pet, to facilitate handling of the pet in familiar or especially unfamiliar environments, such as veterinary offices, groomers, kennels or during transporting. The clamshell hinges at one end, preferably a caudal end, so it may be applied from behind the pet and the two halves biased medially to close the shell about the pet&#39;s head, prior to latching the halves closed. Openings may be provided for access to the pet&#39;s ears, nose, teeth, and/or mouth. A pleasant sensory zone (PSZ) or module may be added to quiet and appease the pet and habituate them to the headgear through positive reinforcement."], "input": "[0001]    This applications claims priority to U.S. provisional application No. 62/290,226 filed Feb. 2, 2016, which is incorporated herein in its entirety. \n     \n    \n     BACKGROUND OF THE INVENTION \n       [0002]    The present invention relates generally to pet-handling accessory items and, in particular, to a headgear for pets that includes a sensory module that aids in acclimating the pet to the continued or repeated use of the headgear. \n         [0003]    Throughout the course of a pet&#39;s life there are many instances where restraint must be used to achieve a desired result, such as pet care or transportation. The restraint may be necessary to protect the caregiver, the owner or even the general public. A routine visit to a care giver, such as a veterinarian or a groomer, may also result in a situation where the caregiver needs access to eyes, ears, nose, mouth, teeth, etc. of the animal for proper care giving. In this respect, many existing muzzles and restraints are unsuitable or at least lacking me meeting all the criteria. Similarly, transporting a pet, whether by bus, car, train, air, or boat, and whether to a local kennel, the caregiver, or even to a private household, may require a restraint for the safety of all nearby. \u201cPets\u201d specifically refers to a domesticated or tamed animal kept for companionship or pleasure and treated with care and affection. Dogs and cats are the most common, but certainly not the only, types of \u201cpets\u201d amenable to this invention. \n         [0004]    For cats, there are only a couple different options for restraint. The first is a quick slip-on muzzle that covers the eyes and attaches behind the head of the cat. This design is often hard to size, easy for the cat to remove, and very difficult to attach as it is applied from the front where the cat can physically fight back. This often leads to mishandling and can cause injury and potential health problems for the handler and the pet. The other design is a heavy plastic ball that is put over the animals&#39; entire head and covers all access points. It has proven to be impractical in professional settings for certain treatment modalities and for smaller animals, and is somewhat pricy for the average pet-owner. \n         [0005]    For dogs, there are more styles and variations on the market but they all tend to have the similar issues. The dogs who don&#39;t want the muzzle to remain on can often slip out of it, they are all applied from the front where the animal can see it and fight back. They tend to be difficult to size, often produce discomfort, and durability is often cited as an issue. \n         [0006]    A number of muzzles exist and are commercially available. For example, the following table identifies a number of known muzzles. \n         [0000]    \n       \n         \n               \n               \n               \n               \n               \n             \n           \n               \n                   \n               \n               \n                 Product \n                 Features \n                 Strengths \n                 Weaknesses \n                 Sources \n               \n               \n                   \n               \n             \n             \n               \n                 Guardian Gear \n                 Fully adjustable \n                 Stops cats from \n                 Attaches  \n                 Online \n               \n               \n                   \n                 strap \n                 biting and chewing \n                 from front \n                   \n               \n               \n                   \n                 Made from strong \n                 Lined with chafe \n                 Difficult to secure \n                   \n               \n               \n                   \n                 nylon fabric \n                 free inner seams \n                 Velcro\u2009\u2122 straps \n                   \n               \n               \n                   \n                 Quick release \n                 for added comfort \n                 Cat can remove \n                   \n               \n               \n                   \n                 buckle \n                   \n                 Blinds the cat \n                   \n               \n               \n                   \n                   \n                   \n                 causing stress \n                   \n               \n               \n                 Four Flags  \n                 Water and dirt \n                 Very durable \n                 Attaches  \n                 Four Flags  \n               \n               \n                 Quick Muzzle \n                 resistant nylon \n                 Form fitting, \n                 from front \n                 Over Aspen \n               \n               \n                   \n                 cloth \n                 making it difficult \n                 Covers the eyes \n                 Online \n               \n               \n                   \n                 Quick closure \n                 for cats to remove \n                 which can cause \n                   \n               \n               \n                   \n                 hook-and-loop tab \n                   \n                 fright/stress \n                   \n               \n               \n                 Soft Paws \n                 Unique design \n                 Allows animal to \n                 Attaches  \n                 Soft Paws \n               \n               \n                 Air Muzzle \n                 allows for easy \n                 see, reducing stress \n                 from front \n                 Online \n               \n               \n                   \n                 attachment \n                 Optional attachable \n                 Too heavy for \n                   \n               \n               \n                   \n                 Open front \n                 oxygen mask  \n                 smaller animals \n                   \n               \n               \n                   \n                 Adjustable joint \n                 Adjustable joint \n                 Impractical for \n                   \n               \n               \n                   \n                 for proper fit \n                 provides a secure \n                 long term use \n                   \n               \n               \n                   \n                   \n                 fit every time \n                   \n                   \n               \n               \n                 Co. of Animals \n                 Ergonomically \n                 Maximizes safety \n                 Easily removed  \n                 PETCO \n               \n               \n                 Baskerville \n                 designed strapping \n                 for owner \n                 by animal \n                 Online \n               \n               \n                   \n                 Soft neoprene \n                 Tough and durable \n                 Sizing is difficult \n                   \n               \n               \n                   \n                 padding \n                 Comfortable  \n                 for consumers \n                   \n               \n               \n                   \n                 Quick and  \n                 for a pet \n                 Cumbersome \n                   \n               \n               \n                   \n                 easy fit \n                 Allows to drink \n                 on/off \n                   \n               \n               \n                   \n                   \n                 and pant \n                 Basket size  \n                   \n               \n               \n                   \n                   \n                   \n                 too small \n                   \n               \n               \n                 Great Choice \n                 Breathable  \n                 Comfortable \n                 Difficult sizing \n                   \n               \n               \n                   \n                 mesh material \n                 Prevents biting, \n                 Attaches from \n                 PetSmart \n               \n               \n                   \n                 Safe and humane \n                 chewing and \n                 front \n                 Online \n               \n               \n                   \n                 Padded in  \n                 barking without \n                 Easily removed \n                   \n               \n               \n                   \n                 contact areas \n                 catching hair \n                 Not easily adjusted \n                   \n               \n               \n                 Petco Nylon \n                 Quick fitting \n                 Allows for \n                 Difficult to size \n                 PETCO \n               \n               \n                 and Mesh \n                 Strong,  \n                 drinking, panting \n                 Very easily \n                 Online \n               \n               \n                   \n                 breathable \n                 and treat feeding \n                 removed \n                   \n               \n               \n                   \n                 nylon \n                 Soft and \n                 Only viable for \n                   \n               \n               \n                   \n                 Flexible \n                 comfortable \n                 small dogs \n                   \n               \n               \n                   \n                   \n                   \n                 Attaches  \n                   \n               \n               \n                   \n                   \n                   \n                 from front \n                   \n               \n               \n                 Veterinary \n                 Fits a wide variety \n                 Comfortable  \n                 Very difficult  \n                 Online \n               \n               \n                 Solutions \n                 of dogs and cats \n                 for animal \n                 to attach \n                   \n               \n               \n                   \n                 Utilizes minimal \n                 Hard to remove \n                 Attaches  \n                   \n               \n               \n                   \n                 restraint \n                   \n                 from front \n                   \n               \n               \n                   \n                   \n                   \n                 Hard to size \n               \n               \n                   \n               \n             \n          \n         \n       \n     \n         [0007]    However, available muzzles suffer from one or more drawbacks, such as blocking of vision of the animal, discomfort of fit, inability to eat or drink, difficulty in breathing or panting, and difficulty in putting the muzzle on the pet. \n         [0008]    Also known are restraints such as the encapsulating sphere with sleeve collar as taught in U.S. Pat. Nos. 6,082,309 and 6,227,148, both to Wexler. These are ball-like or globular devices that include a polar opening for insertion of the pet&#39;s head and a sleeve or collar extending along the neck of the animal. Among the problems of existing muzzles and restraints is the need to approach the animal anteriorly (from the front) in order to equip the pet with the restraint. \n         [0009]    Almost universally, the pet prefers not to be so-restrained, so the use of muzzle restraint can be a source of anxiety to the pet. Consequently, pets often come to associate the muzzle with \u201cbad\u201d events (e.g. strange smells, strange sounds, and strange sensations and manipulations); and over time the pet may come to resist the use of it. This learned resistance further complicates the use of muzzles since, at first sight the pet may hiss, snarl, growl, bite, scratch or otherwise express its displeasure with the notion of wearing the muzzle. Pet bites account for a number of significant injuries to pet handlers. In a survey, 67% of respondents indicated receiving a bite or scratch from a cat, and 48% had suffered a dog bite. The New England Journal of Medicine reports that between 28% and 80% of bites and scratches develop in to infections. Some estimates indicate that about 30% of hand bite injuries require some hospitalization (J. Hand Surgery). \n         [0010]    It would therefore be advantageous if improved headgear existed that would address these drawbacks. \n       SUMMARY OF THE INVENTION \n       [0011]    The invention relates generally to a muzzle or headgear for an animal. In general, the headgear comprises: \n         [0012]    a pair of half clamshell portions each having periphery complementary to the other, and a cup-like concavity adapted collectively to fit about the head of an animal, the periphery defining a rostral end and a caudal end relative to the animal, the pair of half portions being connected at least one point along the periphery of the clamshell portions to form a flexible hinge joint; and \n         [0013]    a fastener mechanism positioned at the periphery opposite the flexible hinge joint and adapted for securing the clamshell portions together. \n         [0014]    In some embodiments of the headgear, the flexible hinge joint is located at the caudal end and the fastener is located at the rostral end to enable fitting the headgear to the animal from a posterior direction. In some embodiments of the invention the clamshell portions are sized and shaped to fit closely about the head of the animal. In such embodiments, each clamshell portion may define an opening through which the ears of the animal may protrude and, optionally, an opening through which the eyes may see. The headgear may also include padding on the inside of the concavity for comfort during longer instances or even continuous wearing. \n         [0015]    In some embodiments, the clamshell portion comprises a solid, transparent material. In other embodiments, the clamshell portion comprises bands or straps that define a loose mesh material. \n         [0016]    In some embodiments, the headgear further comprises a pleasant sensory zone disposed in the headgear to deliver a pleasant stimulus to the animal while wearing the headgear. A pleasant sensory zone (PSZ) is an area that incorporates a feature that gives a pleasant stimulation of one or more of the senses of the pet while the pet wears the head gear. Such stimulus may be, for example, audible and placed hear the ear; olfactory and placed near the nose; or an edible \u201ctreat\u201d made accessible near the mouth; or a combination of any of these. For example, the pleasant sensory zone may be loaded with a stimulus selected from a pheromone, a flavoring agent, and a pet treat. These PSZ&#39;s are described in more detail below. \n         [0017]    In another aspect, the invention includes a method for using the headgear. The method comprises: \n         [0018]    approaching the animal from the rear with the clamshell portions of the headgear separated or opened; \n         [0019]    closing the clamshell portions together about the head of the animal from behind with the caudal end of the periphery at the animal&#39;s neck and the rostral end at the animal&#39;s mouth and nose; and \n         [0020]    securing the fastener mechanism at the rostral end. \n         [0021]    The method may further include delivering a pleasant sensory stimulus to calm the animal. The methods may be used from many purposes, including travel, veterinary examination and medical or grooming procedures. In particular embodiments, the method may be used to habituate an animal to a potentially stressful environment through positive reinforcement; and/or protecting a wounded animal from aggravating the wound, a bandage or a cast in the area of the wound. \n         [0022]    The unique design and construction of the headgear allows for risk-free handling of companion animals in any setting, allowing for more frequent vet visits, easier grooming trips, and an overall better relationship between pets, owners, and professionals. The headgear is constructed out of a pliable yet rigid material and may be mesh or see through allowing the animal to have full eyesight and the ability to drink or receive treats. This design stands out from any other muzzle on the market because it is applied from behind the animal, so before they have a chance to fight back they are already inside of the muzzle and can cause no harm to themselves or the handler. Along with this innovative way to approach the animal, there are a host of additional unique features that the \u201cclamshell\u201d headgear may provide. \n         [0023]    Another key feature of some embodiments of present invention is inclusion of a hinge portion in the caudal or dorsal area of the head gear. This allows the pet to be approached posteriorly (from behind) which is generally a safer route. The caudal/dorsal hinge portion joins the clamshell portions at the neck, allowing the clamshell halves to be swung medially to join and latch in the rostral/ventral area. \n         [0024]    Another key feature is that the comfortable nature of the headgear allows it to be wearable 24 hours a day, 7 days a week, except possibly for times of solid food intake. The animal is generally able to drink using a suitable mouth opening. \n         [0025]    Another key feature is a method for handlers to treat the animal without risk of bite or aggression. Accordingly, this method comprises: \n         [0026]    fitting an animal with the headgear as described herein, \n         [0027]    closing and securing the clamshell portions together about the head of the animal; and \n         [0028]    treating the animal, wherein treating in the animal further comprises a treatment selected from dental treatment such as tooth or gum cleaning, oral surgery, etc., medication treatment such as the oral administration of antibiotics, anti-worm medications, vitamins or other medicines, hygiene treatment, feeding treatment, surgical treatment, ophthalmic treatment, or training treatment. \n     \n    \n     \n       BRIEF DESCRIPTION OF THE DRAWINGS \n         [0029]    The accompanying drawings, incorporated herein and forming a part of the specification, illustrate the present invention in its several aspects and, together with the description, serve to explain the principles of the invention. In the drawings, the thickness of the lines, layers, and regions may be exaggerated for clarity. \n           [0030]      FIGS. 1A, 1B, and 1C , illustrate one half clamshell portion of a first, solid embodiment in plan views (top and bottom); front and rear elevation views; and right and left side elevation views, respectively. \n           [0031]      FIG. 1  D illustrates the two clamshell halves of the embodiment of  FIGS. 1A, 1B, and 1C  in a perspective view. \n           [0032]      FIGS. 1E, 1F, and 1G  illustrate an alternate solid embodiment showing both clamshell halves in top closed view, top open view, and open inside views, respectively. \n           [0033]      FIGS. 2A, 2B, and 2C  illustrate a different mesh embodiment showing both clamshell halves in a top-caudal perspective view, a top-lateral perspective view, and a rostral-lateral perspective view, respectively. \n           [0034]      FIG. 2D  is an enlarged cross-sectional view of an area near the rostral end for illustrating one embodiment of a PSZ. \n           [0035]      FIG. 3  illustrates a pet and the anatomical directional terminology for pets, some of which is used in describing this invention. \n           [0036]      FIG. 4  illustrates another embodiment of the clamshell headgear. \n           [0037]      FIGS. 5A and 5B  illustrate different embodiments of the clamshell headgear, showing some features adapted for a cat. \n           [0038]      FIG. 6  illustrates a different embodiment of the clamshell headgear, showing some features adapted for dog. \n       \n    \n    \n       [0039]    Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, when read in light of the accompanying drawings. \n       DETAILED DESCRIPTION \n       [0040]    The terms, \u201cmuzzle\u201d, \u201cheadgear\u201d and \u201chelmet\u201d may all be used interchangeably to describe this invention. The term \u201cclamshell\u201d halves or portions, refers to a pair of complementary shapes, each generally defining a concavity and having a periphery that is complementary to the other \u201cclamshell\u201d half or portion. \u201cComplementary\u201d in this regard includes a straight or planar periphery as well and one marked by alignment or indexing features such as teeth or pins and receiving sockets or other detentes that are used to ensure proper alignment of the clamshell halves when closed. The need for these depends in part on the rigidity of the hinge. Although the surface of a marine clamshell may be continuous, surface continuity is not required of the headgear disclosed herein. The shape surfaces may be continuous except for suitable holes or orifices defined therein as explained herein; or they may be discontinuous, such as one made of strips of material to form a loose mesh-like structure. \n         [0041]    \u201cPets\u201d refers generally to a domesticated or tamed animal kept for companionship or pleasure and treated with care and affection. Dogs and cats are the most common, but certainly not the only, types of \u201cpets\u201d amenable to this invention. Primates, pigs, goats, sheep, birds, lemurs, ferrets and other types of animals have also been reported as pets, and this list is still not exhaustive. Although the description may refer to the more typical pets, it will be understood that the invention is broadly applicable to any animal, domesticated or not, that has a head and mouth. \n         [0042]    \u201cHandlers\u201d refers to anyone who is responsible for moving, transporting, or manipulating the pet in any way. This explicitly includes owners and family members of owners; caregivers such as veterinarians, veterinary dentists, groomers, trainers, instructors, kennel operators, zoo personnel, etc.; and implicitly includes any other party meeting the general definition. \n         [0043]    Referring to  FIG. 3 , the head or nose of an animal is referred to anatomically as the anterior end and the tail is referred to as the posterior (sometimes caudal) end. In organisms, that have distinct heads (such as cats, dogs, birds, primates, and most other vertebrates) the anterior end is sometimes referred to as the rostral or cranial end. While \u201canterior\u201d/\u201cposterior\u201d has broader applicability for all animals, applicant prefers rostral (for nose or beak) and caudal (tail) as directional terms. This is consistent with Nomina Anatomica Veterinaria, and with common usage in veterinary medicine. Moreover, given that the invention relates to headgear, cranial might be confusing. Of course, dorsal/ventral, medial/lateral, proximate/distal and other anatomical terms may also be used in the description. \n         [0044]    Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described herein. All references cited herein, including books, journal articles, published U.S. or foreign patent applications, issued U.S. or foreign patents, and any other references, are each incorporated by reference in their entireties, including all data, tables, figures, and text presented in the cited references. \n         [0045]    Numerical ranges, measurements and parameters used to characterize the invention\u2014for example, angular degrees, quantities of ingredients, polymer molecular weights, reaction conditions (pH, temperatures, charge levels, etc.), physical dimensions and so forth\u2014are necessarily approximations; and, while reported as precisely as possible, they inherently contain imprecision derived from their respective measurements. Consequently, all numbers expressing ranges of magnitudes as used in the specification and claims are to be understood as being modified in all instances by the term \u201cabout.\u201d All numerical ranges are understood to include all possible incremental sub-ranges within the outer boundaries of the range. Thus, a range of 30 to 90 units discloses, for example, 35 to 50 units, 45 to 85 units, and 40 to 80 units, etc. Unless otherwise defined, percentages are wt/wt %. \n       Clamshell Headgear \n       [0046]    Referring first to  FIGS. 1A-1C  and  FIG. 4 , one embodiment of the headgear  10  is illustrated showing the \u201cclamshell\u201d nature of the head gear  10 , having two portions  10   a  and  10   b , joined at a hinge area  12 . Throughout this description a reference numeral, (e.g.  6 ) may have a suffix \u201ca\u201d (e.g.  6   a ) for a right-side part, and a suffix \u201cb\u201d (e.g.  6   b ) for a corresponding or complementary left-side part, relative to the animal.  FIG. 1A  shows only the right half portion  10   a  in top and bottom views; while  FIG. 1B  shows only the right half portion  10   a  in rostral (front) and caudal (rear) views. Each of the half portions  10   a  and  10   b  define a periphery  11   a , 11   b  that is complementary to periphery of the other side, and are cup-like or arcuate defining a cavity  13  for enclosing a spherical-like head. At a caudal area  19  of the periphery  11  (near the hinge area  12  in this embodiment), each of the half portions  10   a  and  10   b  also define semicircular recesses  14   a  and  14   b  that together form a generally circular opening to accommodate the neck of the animal. At the apex of a rostral end  21 , there may be one or more openings  17  to admit air and or light to the interior cavity  13 . The embodiment of the headgear  10  illustrated in  FIGS. 1A to 1C  may be solid, but preferably transparent. \n         [0047]    Near the rostral end  21  of the clamshell headgear  10  is a fastening mechanism such as latch  16 , which typically comprises a first portion  16   a  on half  10   a , and a complementary portion  16   b  located on half  10   b . The fastening mechanism may comprise one or more latches that hold the headgear closed securely about the head. Generally at least one latch is in a rostral area opposing the hinge area. As shown in  FIGS. 1E to 1G  in particular, the latch  16  is generally opposite from the hinge  12 . Alternative locations for fastening mechanisms that may still oppose the hinge area include the ventral neck area below the jaw and/or forehead area near the eyes. Other fastening mechanisms are described below. A pleasant sensory zone (PSZ)  40  may optionally be incorporated at or near the rostral end  21  of the headgear  10 . These also are described below. Also shown in this embodiment in  FIG. 4  is a ring  18  or other attachment point for a leash. The ring  18  may appear on one or both halves  10   a ,  10   b  of the clamshell headgear  10 . \n         [0048]    Referring now to  FIGS. 1D to 1G , an embodiment is illustrated wherein the device may be solid and not transparent, but includes orifices  20   a , 20   b  for ears, orifices  22   a , 22   b  for eyes, and orifice  17  or slots  24   a , 24   b  for mouth/nose or other ventilation. In this way the pet can see externally. In other variations, the slots may also be replaced with a single extended opening (as shown in  FIG. 5A ) so that the handler can better see into the pet&#39;s mouth. The ear orifices  20  also permit the headgear  10  to be smaller and lighter and fit closely to the head of the animal for a more secure, tighter fit. Especially in closely-fitted headgear, it may be desirable to provide cushioning or padding  26   a ,  26   b  in areas of the device that might rub on parts of the animal&#39;s head, causing irritation. Headgear that closely fits the head will have skull-following contours either molded into the device or as a result of selective padding in the interior of the headgear. \n         [0049]    A second embodiment is illustrated in  FIGS. 2A to 2C . In this embodiment, the headgear  30  is composed of two halves  30   a ,  30   b  fabricated as a loose mesh material of criss-crossing bands that also allow for visibility and breathing. Higher strength, thicker sagittal bands  52   a  and  52   b  form the periphery of each clamshell half along a mid-sagittal plane. Similar wider or reinforced coronal bands  52   a , and  54   b  may be used in a coronal plane to provide a more rigid clamshell shape. The remainder of the headgear  30  is formed of either solid material like front wall  60 , or the intermediate bands  56  that form a loose mesh or a combination of these. The headgear  30  includes a hinge area  32 , typically at a caudal end  39  opposing the rostral end  41 , and semicircular recesses  34   a ,  34   b  that form the neck opening. In some embodiments, headgear  30  may include fenestrations, openings, or orifices  41   a ,  41   b  for ears, orifices  42   a ,  42   b  for eyes, and orifices for mouth as well (not shown in  FIGS. 2A-2C ). However, unless otherwise indicated, both the solid headgear  10  and the mesh or open headgear  30  may have similar features and advantages and will be described together. \n         [0050]    The clamshell half portions may be sized in various dimensions to define a cavity  13  and orifices that accommodate the varied nose size and head shapes of pets of different genus, species, or breeds. For example a large size cup is required to encase breeds such as Great Danes, Newfoundlands or St. Bernards; while much smaller cup portions are required for smaller breeds such as Chihuahuas, Shih-Tzus, and many \u2018miniature\u2019 breeds. A special version may be devised for Pugs, as they have almost no rostral protrusion. Similarly, cats and pets of other species will require headgear halves proportioned for their respective noses.  FIGS. 5-6  further illustrate embodiments for different species. \n         [0051]    Referring to  FIGS. 1, 2 and 4 , the clamshell headgear comprises two half-shell portions that are hinged or fastened together. The hinge area  32  may be reinforced with thicker or wider sections as best shown in  FIGS. 2A and 2B . The hinge may comprise a \u201cliving\u201d hinge as is well known in the injection molding arts, and the halves can easily be molded as one unit. Alternatively the hinge may be fabric, as shown in  FIG. 1G , or other material. \n         [0052]    In some embodiments, the hinge may be located rostrally. These embodiments are generally positioned on the pet&#39;s head from and anterior perspective. Embodiments that have a hinge along a top or superior aspect of the head gear are generally put on from a superior approach; embodiments that have a hinge along a lower or inferior aspect of the head gear are generally put on from below, using an inferior approach; and embodiments that have a hinge along a lateral aspect of the head gear would be put on using a right or left lateral approach. In a more preferred variation, the hinge is located at a caudal part of the headgear, allowing an approach posteriorly. As noted, this is advantageous in that the pet will not see the device approaching and will not enter the anxiety and resistance modes so quickly. \n         [0053]    At the aspect of the clamshell headgear opposing the hinge is a fastener or latch mechanism. The fastener or latch may comprise any type of device suited for securing the two clamshell halves together about the pet&#39;s head. Illustrative types of fasteners include buckles (e.g. quick release, side release, and conventional), snaps, hook-and-loop fasteners (such as Velcro\u2122 brand), resilient clips or tabs with detents that may insert under opposing clips, tabs or slots, or other securing mechanism may be used to secure the two halves together. As best shown in  FIG. 2C  near the rostral end  41 , the sagittal band area may be reinforced with thicker or wider band sections or a solid portion to accommodate a fastening mechanism. Alternatively, the latch may be located at a rostral end or simply at the ventral side of the neck, relying on the size of the neck relative to the base of the skull to secure the device. \n         [0054]    While right and left halves that part along a sagittal plane are depicted in  FIGS. 1 and 2 , it will be understood that the halves may also part along a transverse plane, producing top and bottom halves instead of right and left halves. In the case of transverse plane top and bottom halves, the hinge and fastener are located on opposite lateral sides of the headgear, and the headgear is brought near to the animal&#39;s head from the side containing the hinge. \n         [0055]      FIGS. 5A and 5B  show an alternative embodiments of the headgear  110 ,  210  in a closed position about the head H of an animal such as a cat. The hinge area  112  lies at a caudal position. In the embodiment of  FIG. 5A , and there are openings  120 ,  122  and  124  to allow access to the animal&#39;s ears, eyes and nose/mouth, respectively. These openings allow a handler access for examining, treating, feeding, dosing medication or other necessary activity associated with the ears, eyes and nose/mouth of the animal. Recess  14   a  is shown for the animal&#39;s neck. In phantom, a variation is shown having an elongated neck or collar portion  128  if there is a need or desire to restrict flexion of the neck. Latch  116  is shown along the ventral side of the neck, although it could alternatively be anywhere under the chin area up to the rostral tip. A PSZ  40  for taste or smell sensations may be located between the eye opening  120  and the nose/mouth opening  124  at the rostral end. \n         [0056]    The openings  122 ,  124  over the eyes and nose/mouth may be completely open, or they may have solid inserts (not shown) with air perforations for breathing and/or made of transparent material for sight, or opaque material if the animal tends to be calmed by less visual stimulation. \n         [0057]    In the embodiment of  FIG. 5B , the headgear  210  is of a mesh construction similar to the embodiment of  FIGS. 2A-2C , and having recesses  234  to define a neck opening, a fastening latch mechanism  216 , and web or band members such as  256 . A PSZ may or may not be present. Although the animal shown in  FIGS. 5A and 5B  is a cat, this same type of headgear could also be used on a dog or other animal, with only minimal modifications to size the headgear to closely fit the animals head; for example elongating the headgear in a caudal-rostral dimension for a dog having a longer jaw and nose area, or adjusting the locations of ear and/or eye openings to be suitable for the dog or other animal. \n         [0058]      FIG. 6  illustrates another embodiment of the headgear  310  in a closed position about the head H of a dog. The halves of the clamshell are again hinged at a caudal location  312 . The neck or collar portion  328  is shown in a moderately extended position, but may extend even further if desired to minimize or prevent neck flexion as shown in phantom. There is little coronal aspect to this embodiment. The head and eyes are relatively free. However, there is a rostral portion  330  that is fairly lengthened in order to prevent bites. Latch  316  and leash attachment  318  are also shown in this embodiment. \n         [0059]    In some embodiments, the headgear device can act as a base for attachment of novelty headgear such as reindeer ears, bunny ears, baseball caps, sun shades, rain gear, etc. It can also act as an attachment point for Halloween type masks and costumes. In some cases, the headgear, with or without other attachments can help promote wound healing by restricting the animal&#39;s ability to lick or bite at the wounded area. In this sense, it can act like the well-known \u201cElizabethan collar\u201d restraints but is infinitely more comfortable and tolerable than the traditional cone of shame collars in present use. \n         [0060]    In use, the headgear is easily placed about the pet&#39;s head and secured. In PSZ embodiments, the PSZ may be preloaded with an appropriate stimulus for the particular pet as discussed above. Alternatively, the headgear may be fitted first, and the stimulus is loaded into the headgear in situ. \n         [0061]    The location of the hinge generally dictates the direction of approach to the pet. Since the fastener is on an opposite side as the hinge, the clamshell opening is with the latch and that side must be brought towards the pet first. This is why the caudal hinge location is a preferred embodiment\u2014it allows the handler to fit the headgear posteriorly, from behind the pet. The handler then biases or presses the clamshell halves closed about the head. For sagittal plane (right and left halves) the bias is towards a medial direction to the mid-sagittal plane; while for coronal plane embodiments, the bias is from a ventral and dorsal extreme toward the midline. The biasing force is easily delivered by the handler&#39;s hands. Another advantage of the caudal hinge embodiment is that the hands and arms of the handler doing the biasing remain behind the animal, relatively safe from bites or scratches. \n         [0062]    Once closed, the fastener of the headgear is secured, clamping the two halves together. The device allows restraint for such procedures as examination, venipuncture, pedicures, bathing, and grooming. \n         [0063]    In other uses, the device is useful for socializing and training an animal. In some situations, and aggressor animal may need to be restrained to prevent it from harming another anima. Thus the invention includes a method to mitigate injury from interspecific and intraspecific interactions such as aggression between two dogs or two cats, or a cat and a dog. This can allow training and socialization in situations in which the aggressor could not be trusted with the non aggressor, or to prevent escalation of aggression between animals. A leading cause of death for dogs under the age of 3 is due to poor socialization which results in fear and associated aggression. A critical socialization period for dogs is between 3 weeks and 3 months of age. Animals not well socialized during this time can become more fearful and aggressive when they encounter new dogs, new people, unfamiliar situations that interfere with appropriate socialization later. The headgear can protect people and other animals during these interactions so that the animal can learn appropriate behavior. It can also mitigate dangerous behavior and allow the animal to coexist. \n       Other Features and Advantages \n       [0064]    Construction: \n         [0065]    The clamshell headgear material will be lightweight, durable, and somewhat flexible. It will also need to be fairly strong and tactile so that the handler has no issues manipulating or maneuvering the animal. A couple of potential materials are mesh wire coated in plastic, or a synthetic plastic that would be injection molded. An animal will react negatively towards the headgear if it is any way uncomfortable for them, so, along with custom sizing, this design is made from a lightweight material so it is almost weightless for the animal wearing it. Color: The color of this product can vary greatly. There will be different options for purchase such as a deluxe model and a standard model. In the deluxe model there could be any color produced and for the standard they may only be a few colors offered. \n         [0066]    Custom Sizing and Fit: \n         [0067]    Not every animal will have the same size or shape of the head. The \u201cclamshell\u201d headgear will come in a variety of sizes and offer a superior fit than any other product on the market. This custom sizing ensures that the headgear will not be removed during use and will be comfortable for the animal. In some embodiments, inside of the headgear there is optionally another layer of security and comfort added. A soft wrap or padding may be employed in animals needing only limited restriction. By utilizing technology similar to that of an air cast one can reproduce a \u201chug\u201d effect on the animal. This serves to reduce stress and calms the animal, making the restraint more acceptable, which is important for fractious animals and reduces the need for repeated sedations. \n         [0068]    Enhancements Useful for Medical or Veterinary Uses: \n         [0069]    Ear, Mouth, and Eye Access: \n         [0070]    The headgear preferably has openings for access to the ears, eyes, and the mouth. This is extremely important in veterinary and veterinary dental settings where the animal may need to have routine examinations and/or medicine applied to these areas. Use of the device facilitates and aids in administration of oral treatments and medications; dental treatment and medications; ophthalmic treatments and medications; and ear treatments and medications. Grips: Properly positioned grips are preferably built-in to the headgear to allow for safe manipulation of the animal&#39;s head without risk of injury. This is especially important for medical treatment caregivers, when blood needs to be drawn from the animal. Ear clamp: The implementation of an ear clamp will serve two main purposes. The first is to secure the ear during procedures and examinations, and the second is to get a pulse rate from the animal to know when dangerous levels are being approached. This is added security for the handler and the patient. Plastic Cover: A plastic cover or \u201covershell\u201d that goes around the \u201cclamshell\u201d headgear will be developed as well so once the headgear is applied, the animal can be isolated within it. This case can serve as an oxygen mask and also a way of anesthetizing the patient. Oral speculum: An oral speculum is another feature that could be added to the headgear. This speculum would hold the mouth open during examinations and procedures reducing the risk of a bite. Fixation and venipuncture: A feature of the headgear is that it allows the head and neck area to be immobilized, particularly if the neck collar extension  128  is employed. This may be useful in treating neck injuries. In addition, with or without the collar extension, a jugular venipuncture is more easily accomplished to draw blood samples if the head and neck are immobilized through use of the headgear device. Sensors &amp; Indicators: The headgear may be fitted with sensors and indicators that provide useful information about the animal&#39;s biological or physiologic status. It may include lights that vary in color or number (e.g. red, yellow, green) to indicate dangerous or safe conditions. Such sensors may also be useful in a positive reinforcement feedback loop that operates to release the pleasant stimulus in response to sensors that detect a calm and relaxed physiologic state, so as to reinforce this desired behavior. This feature is particularly useful for training purposes. \n       Pleasant Sensory Zone \n       [0071]    As noted above, a key aspect of the invention is the pleasant sensory zone (PSZ) or module that is designed specially to appease the pet and reduce the anxiety and stress caused by strange handlers, strange environments, and foreign smells sounds and sights, and strange, unusual and sometimes uncomfortable manipulations or procedures. The PSZ is designed to pleasurably stimulate any of the pet&#39;s senses, specifically one or more of the senses of: vision/sight, olfactory/smell, auditory/sound, taste, and tactile/touch. The PSZ may be incorporated as a module or portion of the headgear that facilitates the delivery of a pleasant sensory stimulus to the proper area of the pet receptors for receiving that stimulus. For example, as discussed below, pheromones or flavors might be includes in a PSZ near the pet&#39;s nostrils at a rostral end of the headgear. Similarly, a tactile PSZ might be included along a portion of the headgear adjacent a ventral neck or chin area or a dorsal nape of the neck area; while an auditory stimulus would be included near the ear(s). \n         [0072]    Flavor Port: \n         [0073]    A flavor port located at a rostral portion near the mouth would provide a host of benefits for the handler. This allows for easy distraction of the animal during procedures, helps habituate them to the headgear through positive reinforcement, and reduces stress. For dogs, this might include peanut butter, bacon or other treat. For cats, tuna, catnip or chicken might be preferred. This port may stimulate gustatory receptors, olfactory receptors, or both. A specific embodiment of a flavor port type of PSZ  40  is illustrated in cross-section in  FIG. 2D . In the clamshell portion near the rostral aspect, the wall  60  forms an opening  62  through which a wafer or disk  64  of candy or other treat may be exposed and smelled or licked by the animal. Extension wall  66  extends outwardly and around the disk or wafer  64  to form a pocket between the wall  60  and extension wall  66 . At one end or top of the pocket an extension wall may be eliminated to allow the handler to slide the wafer or disk  66  into the pocket from outside the headgear to provide the stimulus for the animal. Flanges  68  of wall  60  extend beyond the limit of extension walls  66  to hold the wafer or disk  64  in the pocket so it cannot immediately be eaten by the animal. \n         [0074]    An alternative flavor port takes the form of a treat dispenser that, upon activation, dispenses a candy or other treat though an opening into the cavity  13  for the animal to eat. The PEZ candy dispenser loaded with animal treats is a suitable mechanism that could be used in for this type of flavor port. \n         [0075]    Pheromone Infused: \n         [0076]    To help make the headgear more attractive for the animal the use of pheromones could be applied as an olfactory stimulus. By infusing the headgear with specific pheromones in a PSZ area near the nostrils, it will reduce the stress levels for the animal, and have a calming effect. The pet may actually learn to enjoy wearing the device, and it may in turn be used more frequently and with ease. Olfactory stimuli such as pheromones could be delivered using a pocket-like structure described above having a scent infused wafer, but having a perforated barrier in wall  60  rather than a complete opening. This would allow the scent to permeate the perforated barrier while preventing the animal from eating the wafer. \n         [0077]    Auditory Stimuli: \n         [0078]    Pleasing sounds, such as \u201cwhite noise\u201d generators may have a calming effect. Obviously, these PSZs would be located near an ear area of the headgear. Miniature speakers driven by onboard integrated chips and battery power could provide this stimulus. Music might be stored in the chip or preferably communicated to the chip wirelessly from a phone or tablet or computer by using, for example, Bluetooth technology and paring the devices. \n         [0079]    Tactile Stimuli: \n         [0080]    A tactile sensation may be provided by means of finger-like protrusions that \u201cscratch\u201d the pet in key places like under the chin or the neck. Another tactile stimuli might be bumps or ridges that apply pressure to key points on the animal. Such pressure points may include the carotid body to perform a vagal maneuver to slow the heart rate and calm the animal. Other useful pressure points are known to those versed in acupressure techniques. \n         [0081]    Visual Stimuli: \n         [0082]    In some animals, it is calming to \u201cblind\u201d them visual stimuli. In such cases, an opaque cover over an eye opening may have a pleasant and calming effect as a PSZ. \n         [0083]    The foregoing description of the various aspects and embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive of all embodiments or to limit the invention to the specific aspects disclosed. Obvious modifications or variations are possible in light of the above teachings and such modifications and variations may well fall within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["Pharmaceutical composition of skin respiratory factor (SRF), sodium chloride, bicarbonate, fluoride and zinc chloride in a suitable toothpaste vehicle provides effective therapy for gingivitis when brushed on the teeth and gingivae. \n     Pharmaceutical composition of SRF in a viscous composition suitable for application to the gingivae and effective over an extended period of time for healing tissue damaged by gingevitis. A toothpaste tube for packaging a pharmaceutical composition of SRF, sodium chloride, bicarbonate, fluoride and zinc chloride."], "input": "TECHNICAL FIELD \n     Normal gingivae are pink and firmly attached to the underlying alveolar bone. At the enamel-gingival junction, the gingiva forms an epithelial-lined ridge around the teeth. The area between the enamel and the gingivae is called the gingival crevice. Gingivitis develops when large masses of bacteria clog the gingival crevice. \n     Bacteria invade the surrounding area and form a sticky matrix, called plaque. If plaque is left undisturbed, it calcifies into calculus. Bacteria in plaque produce metabolic by-products, enzymes and toxins. These products diffuse into the immediate surrounding area, irritate the gingivae, and, as a consequence, they trigger a localized inflammatory reaction. The gingivae swell, become reddened and extrude crevicular fluid. Depending on the severity of the condition, the gingivae become sensitive to touch and may spontaneously bleed. As gingivitis advances to periodontitis, the supporting collagen fibers and the alveolar bone begin to degenerate. As a result, teeth become mobile and eventually fall out. \n     BACKGROUND ART \n     There are numerous studies that demonstrate that the accumulated plaque at the enamel-gingival junction significantly increases the severity of the gingival disease, while other studies show that when plaque is removed, healthy condition is reestablished. Because of the apparent direct cause and effect relationship between plaque and gingival inflammation, it is widely believed that plaque accumulation is detrimental to gingival health. \n     It has been suggested that if the accumulation of plaque at the enamel-gingival junction can be prevented or at least retarded, the severity of gingivitis and periodontitis can thereby be reduced. \n     A widely studied and much discussed method for maintaining periodontal health or even eliminating periodontal disease is simply using sodium chloride, sodium bicarbonate and hydrogen peroxide as a dentifrice in a thorough oral hygiene program. Five scientific studies have evaluated using sodium bicarbonate and hydrogen peroxide as a dentifrice. \n     These five studies done independently at five different universities totaling 114 patients all showed similar results when evaluating the dentifrices. Sodium bicarbonate and hydrogen peroxide appears to be an adequate dentifrice but is no better than commercially available dentifrices, whether fluoridated, nonfluoridated or powdered. \n     Cerra, M., et al., J. Periodontol. 53:599-603, October 1982. \n     Stoller, N., et al., Presented at the A.A.P. annual session, Research Forum, 1982. \n     Greenwell, H., et al., J.A.D.A. 106:457-461, April, 1983. \n     Wolff, L., et al., J. Dent. Res. 17:537-540, September, 1982. \n     West, T., et al., J. Periodontol. 54:339-346, June 1983. \n     DISCLOSURE OF INVENTION \n     It has now been discovered that the rate of healing of gingivitis, as characterized by inflammation, bleeding and swelling, can be substantially increased by the daily application to the gingivae of a pharmaceutical composition comprising skin respiratory factor (SRF), sodium chloride and bicarbonate, fluoride and zinc ions in a suitable toothpaste vehicle. \n     SRF is a commercial material produced by the method set forth in U.S. Pat. Nos. 2,239,345, 2,320,478 and 2,320,479, which are herein incorporated by reference, and is standardized as units with 1 unit (U) of SRF increasing the uptake of oxygen by minced rat abdominal skin (1 mg dry weight) by 1% in a 1-hr. measurement by Warburg manometry. \n     As an adjunct to the above treatment, a gelatinous adhesive preparation for example with gelatin, carboxymethylcellulose, silica, containing SRF is provided for application to the gingivae. This adhesive preparation can be applied for entended periods and, for example, can provide overnight contact of SRF with the gingivae. \n     Prolonged contact of the SRF with the basic pH, about 8, of the tooth paste vehicle results in some discoloration (darkening) of the SRF. Accordingly, the present invention provides for packaging the pharmaceutical composition in a toothpaste tube wherein the interfacial contact between the SRF and the remaining components of the toothpaste are minimized. Such toothpaste tubes are described in U.S. Pat. Nos. 2,789,731 and 4,098,435. FIG. 1 of the accompanying drawing illustrates the concept of the tube and will be subsequently described in detail. \n     DETAILED DESCRIPTION OF INVENTION \n     The active components of the present pharmaceutical composition are present in the toothpaste vehicle in the following ranges of quantities: \n     Total fluoride: 900-1100 ppm F- \n     Soluble fluoride: 1000 ppm F- \n     SRF: 2700-3300 units/oz. \n     Bicarbonate ion: 13.05-15.95% w/w \n     Sodium Chloride: 4.50-10.5% w/w \n     Zinc ion: 0.108-0.132% w/w \n     In the pharmaceutical compositions of the invention, the bicarbonate, fluoride, and zinc salts that can be used to provide the bicarbonate, fluoride and zinc ions are the pharmaceutically acceptable salts which are compatible with the ingredients of the toothpaste vehicle. \n     In the pharmaceutical composition of this invention, the zinc salts that could be used to supply all or part of the zinc ion, are the chloride, citrate, acetate, lactate, salicylate, and, in general, glycerol soluble, pharmaceutically acceptable zinc salts. The preferred salt is zinc chloride. \n     In the pharmaceutical compositions of this invention, the bicarbonates that could be used to supply all or part of the bicarbonate ion are sodium bicarbonate and potassium bicarbonate. The preferred salt is sodium bicarbonate. \n     In the pharmaceutical composition of this invention, the fluoride salts that could be used to supply all or part of the fluoride ion are pharmaceutically acceptable fluorides such as sodium fluoride, and the like. \n     The active components are incorporated into a suitable toothpaste vehicle containing polishing agents, thickening agents, sudsing agents, humectants, flavoring agents, and sweetening agents. These agents are standard pharmaceutical tools used in these preparations and are not an essential aspect of this invention. Therefore, the amount of these additive materials used can be varied. \n     Any suitable water insoluble polishing agent can be employed in the compositions of this invention, such as, for example, dicalcium phosphate, aluminum hydroxide, calcium carbonate, calcium polymetaphosphate, dicalcium orthophosphate dihydrate, sodium polymetaphosphate and mixtures thereof. \n     If a thickening agent is required, cellulose derivatives such as, for example, sodium carboxumethylcellulose and sodium carboxymethylhydroxyethyl cellulose or natural gums such as gum arabic or gum tragacanth may be employed. \n     Exemplary of sudsing agents which may be employed are, for example, sodium lauryl sulfate, sodium N-lauroyl sarcosinate, sulfonated monoglycerides of fatty acids having from 10 to 18 carbon atoms such as, for example, sodium monoglyceride sulfonates or mixtures thereof. \n     Among the specific compounds which may be employed as humectants are sorbitol, glycerine, polyhydric alcohols of like nature or mixtures thereof. \n     As examples of compounds that may be used as flavoring agents are clove oil, menthol, peppermint oil, spearmint oil, wintergreen oil, sassafras oil and anise oil. Sweetening agents would include compounds such as, for example, saccharin, dextrose, and sodium cyclamate. \n     The following examples together with the accompanying drawing further serve to illustrate the pharmaceutical toothpaste compositions of this invention. \n    \n    \n     EXAMPLE 1 \n     A pharmaceutical toothpaste composition suitable for treatment of gingivitis is formulated from the following ingredients in two separate portions, including a flavor portion, which are then admixed to form the final composition. \n     \n         ______________________________________     First Portion      % ByPhase     Ingredient         Weight______________________________________A         Glycerine 96%      5.00A         Carboxymethylcellulose 7MF                        1.00B         Sorbitol 70%       15.00C         Deionized Water    23.05C         Zinc Chloride      0.25C         Sodium Benzoate    0.10C         Sodium Saccharine  0.25C         Sodium Fluoride    0.22C         Sodium Chloride    5.00C         SRF                1.23C         Sodium Bicarbonate 20.00D         Syloid B-30        13.00D         Sicosil 63M        4.00E         Titanium Dioxide #3328                        1.00E         Sorbitol 70%       2.00F         Sorbitol 70%       5.00F         Sodium Lauryl Sulfate                        2.40F         Flavor             1.50______________________________________ \n    \n     Flavor Portion \n     The flavor portion which is a component of Phase F above is composed of the following ingredients which are weighed and placed into a suitable stainless steel container fitted with a mixer. The mixer is then started and the mixing is continued until all of the menthol crystals have dissolved. \n     \n         ______________________________________               % ByIngredient          Weight______________________________________Cinamic Aldehyde    8.20Menthol, Racemic Crystals               49.30Methyl Salycilate   20.50Peppermint Oil      4.10Spearmint Oil       4.10Clove Oil           13.80______________________________________ \n    \n     The toothpaste is produced according to the following procedure: \n     1. In an appropriate vessel equipped with adequate mixers weigh in glycerine. \n     2. Blend carboxymethylcellulose with glycerine. \n     3. Add sorbitol to Phase A. \n     4. In another vessel, dissolve ingredients of Phase C in order in deionized water. Maintain heat at 50\u00b0 to 70\u00b0 C. for a few minutes. Cool to room temperature. Add to first vessel. \n     5. To a kettle with vacuum draw at least 28 inches of vacuum. Mix under vacuum for 5 minutes. \n     6. Break vacuum and add dry powders of Phase D to batch one at a time under agitation. \n     7. Draw vacuum again. Mix under vacuum for 25-30 minutes. \n     8. Break vacuum. In a separate vessel, disperse titanium dioxide in sorbitol. Add to batch under agitation. \n     9. Dissolve sodium lauryl sulfate, flavor, and color in sorbitol (Phase F). Add to batch. \n     10. Reseal and mix under vacuum for 5 minutes. \n     11. Transfer to storage. \n     EXAMPLE 2 \n     This embodiment of the pharmaceutical composition of the invention will be described with respect to a toothpaste tube or package in which the SRF is separated from the other active ingredients until the time of use. \n     FIG. 1 is a vertical central sectional elevation of a dispensing end of a tube useful in packaging the pharmaceutical composition of the present invention. Referring to FIG 1, collapsible dispensing tube 11 has a side wall 13 lined on the inside surface and a shoulder portion 15 terminating in a neck 17 onto which is pressed and held firmly in place a blending fitting 19, preferably made of synthetic organic polymeric plastic materials, such as nylon or other suitable moldable and form-retaining polymer, preferably of the thermoplastic type. Blending fitting 19 includes a longitudinally extending tubular portion 21, the wall 22 of which is shown tapered and containing internal ribs 23. Wall 22 determines a longitudinal passageway 25. A plurality (usually from 2 to 6 but even single passageways may be employed) of transverse passageways 27, located near the joinder of the shoulder and neck portions of the tube, passes through wall 22. The blending fitting includes an externally threaded outer portion 29 and a dispensing opening 31, which is a continuation of passageway 25. A sealing cap 33 may be screwed onto threaded portion 29 of the blending fitting to prevent unintentional discharge of contents from tube 11. \n     As is illustrated in FIG. 1, initially a first portion of SRF in a suitable vehicle at a pH of about 5 designated 35 is filled into the tube, as is fully described in U.S. Pat. No. 4,098,435, to the level or interface indicated by numeral 37. Preferably then, an &#34;insulating&#34; or protective intermediate layer of non-reactive material 39 is applied and then the second portion of the dentifrice, identified by numeral 41, containing the balance of the periodontal toothpaste ingredients set forth in Example 2 is filled into the tube while the tube is maintained in inverted position, as illustrated. Upon application of pressure to the tube, streams of the first portion of the dentifrice containing SRF pass through openings 27 into passageway 25, forming stripes or &#34;inlays&#34; in the surface of the second portion of the dentifrice in such passageway. Entry of the first portion into the second portion is facilitated by the presence of the &#34;upstream&#34; ribs 23 and a correct and uniform proportion of first dentifrice portion to second dentifrice portion is obtained. Because of the location of the tranverse openings 27, essentially all of the product can be discharged and the dispensed product is of substantially uniform composition throughout dispensing. Ideally, the portion of dispensing passage 31 &#34;downstream&#34; (upon dispensing) of transverse openings 27 will be as short as is feasible so as to minimize contacting of any reactive portions of the dentifrice with each other during storage for any appreciable time between uses. \n     The material of construction of the tube is preferably a conventional polymeric plastic with polymeric plastic cap and blending fitting. The dentifrice and the different portions thereof, the various compositions of which will be described later, will normally be extrudable through the dispensing opening. \n     The number of openings through the dispensing passageway walls will be chosen to regulate the desired proportions of the dentifrices to be discharged. \n     The formulation of the toothpaste of Example 2 is as set forth below. \n     \n         ______________________________________                      % ByPhase      Ingredient      Weight______________________________________A          Glycerine 96%   5.00A          CMC 7MF         1.00B          Sorbitol 70%    15.00C          Deionized Water 24.28C          Zinc Chloride   0.25C          Sodium Benzoate 0.10C          Sodium Saccharine                      0.25C          Sodium Fluoride 0.22C          Sodium Chloride 5.00C          Sodium Bicarbonate                      20.00D          Syloid B-30     13.00D          Sicosil 63M     4.00E          Titanium Dioxide #3328                      1.00E          Sorbitol 70%    2.00F          Sorbitol 70%    5.00F          Sodium Lauryl Sulfate                      2.40F          Flavor          1.50      SRF Concentrate Crude                      *______________________________________ *Adjust concentration of SRF to 3000 units/ounce of product. \n    \n     The flavor component present to the extent of 1.50% by weight contains the ingredients and is produced by the procedure of Example 1. \n     The preparation of the first portion of the toothpaste containing the SRF is as follows: \n     Mix the SRF with one-third of the Sorbitol 70% set forth above for Phase B and one-fifth of the Glycerine 96% set forth above for Phase B. This first portion at a pH of about 5, is first added to the tube of Example 1 and designated 35. \n     A small amount of Sorbitol 70%, i.e. one-fifth of the amount set forth above for Phase F, is added to the tube to separate the SRF first portion from the higher pH second portion. \n     The second portion containing the balance of the ingredients is prepared using the procedure described in Example 1 and then added to the tube and sealed. \n     EXAMPLE 3 \n     The preparation of another embodiment of the periodontal toothpaste of the invention is described below using the following ingredients. \n     \n         ______________________________________                 % w/wIngredient            Q.S. adjust to______________________________________Part IPurified Water Deionized                 100.000Sodium Benzoate, NF (preservative)                 0.100Sodium Saccharin, USP 0.250Sodium Fluoride, USP  0.220Sodium Chloride, USP  10.000Zinc Chloride Granular, USP                 0.250SRF Concentrate Crude *Sorbitol Solution, USP                 22.000Sodium Bicarbonate, USP                 15.000Part IIGlycerin 99 Percent, USP                 3.000CMC 7MF               1.000Part IIIGlycerin 99 Percent, USP                 2.000Part IVSyloid B-30 (Silica Gel HSG-750)                 13.000Sicosil 63M           4.000Titanium Dioxide ANSB Div Sun                 1.000Sodium Lauryl Sulfate, NF                 2.400Part VPeriodontal Toothpaste-Flavor Mix                 1.500______________________________________ *Adjust concentration of SRF to 3000 units/oz. of product. \n    \n     Part I \n     Sodium benzoate, sodium saccharin, sodium fluoride, sodium chloride, zinc chloride and SRF were placed in a suitable container and mixed for 5 minutes. Sorbitol solution was added and stirring continued for an additional 5 minutes. To the mixture was added the sodium bicarbonate and the resulting mixture heated to 60\u00b0 C. with stirring and maintained at that temperature for 10 minutes. The mixture was cooled to 25\u00b0 C. and deaerated. \n     Part II \n     Concurrently the glycerin was placed in a separate suitable container equipped with a stirrer. The carboxymethylcellulose was added with stirring until evenly dispersed. The carboxymethylcellulose dispersion was transferred to the mixture of Part I with the aid of vacuum. To this was added the glycerin of Part III with the aid of rinsing water. The mixture was deaerated and mixed 30 minutes. The viscosity and pH was checked. To this mixture was added a blended mixture of the Syloid, Sicosil, titanium dioxide and sodium lauryl sulfate. The resulting mixture was deareated. \n     To the deareated mixture was added the flavor mix of Part V with the aid of rinsing water. The resulting mixture was stirred for an additional 20 minutes and packaged in toothpaste tubes. \n     The flavor component contains the same ingredients and is produced by the same method as in Example 1. \n     EXAMPLE 4 \n     Another embodiment of the periodontal toothpaste of the invention is described below. \n     \n         ______________________________________                      % ByPhase      Ingredient      Weight______________________________________A          Glycerine 96%   5.00A          CMC 7MF         1.00B          Sorbitol 70%    15.00C          Deionized Water 22.61C          Zinc Chloride   0.25C          Sodium Benzoate 0.10C          Sodium Saccharine                      0.25C          Sodium Fluoride 0.22C          Sodium Chloride 5.00C          SRF             1.37C          Sodium Bicarbonate                      20.00D          Syloid B-30     13.00D          Sicosil 63M     4.00E          Titanium Dioxide #3328                      1.00E          Sorbitol 70%    2.00F          Sorbitol 70%    5.00F          Sodium Lauryl Sulfate                      2.40F          Flavor          1.50G          D &amp; C Red #33 (1%)                      0.30______________________________________ \n    \n     The components are formulated into a toothpaste by the procedure of Example 1. \n     The flavor component present to the extent of 0.30% by weight contains the ingredients and is produced by the procedure of Example 1. \n     The method in accordance with this invention, to treat gingivitis or to induce an anti-gingivitis effect, comprises administering to the oral cavity of an animal organism, preferably humans, suffering from gingivitis, an amount sufficient to retard and treat said gingivitis. \n     The preferred method is by brushing the toothpaste formulation onto the teeth and gums, and rinsing out. The procedure is used three times per day until results conform to the dentist&#39;s treatment desires. \n     In general, the pharmaceutical preparation of the present invention attacks gram-negative and gram-positive bacteria, both the aerobic and anaerobic spirochetes, large virus and certain protozoa, in addition to exercising an antifungal activity for oral infections caused by Candida albicans. It acts as a protective for irritated and inflamed mucous membranes and as an oral lavage, and assists in the removal of tenacious mucus. \n     The antimicrobial activity of the toothpaste of Example 3 was determined against various organisms in an agar diffusion assay according to the following procedure: \n     1. A 24 hour culture of each organism was diluted 1-1000 in sterile saline (1-100 for C. albicans). \n     2. 0.1 ml of this dilution was streaked onto the surface of 3 trypticase soy agar plates. \n     3. One 8 mm well was dug into each plate with a cork borer. \n     4. Each well was filled with the toothpaste. \n     5. The plates were incubated for 24 hours at 35C and then the zones of inhibition were measured in mm. \n     The results are in Table 1. \n     \n                       TABLE 1______________________________________Zone of Inhibitation against various organisms forToothpaste of Example 3 (in millimeters)Organism Well #1   Well #2   Well #3 Average______________________________________C. albicans    50        50        47      49Strep. mutans    42        44        44      43.3Ps. aeruginosa    23        21        20      21.3______________________________________ \n    \n     EXAMPLE 5 \n     \n         ______________________________________           Grams______________________________________Gelatin (finely powdered)             47SRF               3000 units per oz. of productMineral oil       47.5Polyethylene (mol. wt. 21,000)              2.5______________________________________ \n    \n     As a night time adjunct to the above brushing treatment of gingivitis the active ingredient, SRF, may be formulated in a vehicle suitable for topical application to the gingavae. Said formulation is a viscous pharmaceutical composition essentially comprising SRF and an intimate admixture of particulate gelatin with mineral oil containing dispersed therein polyethylene having a molecular weight of at least 3,500 in an amount equal to approximately 0.25% to 50% of the combined weight of polyethylene and mineral oil, the SRF preferably representing about 3000 units per oz. of the composition. \n     (a) A polyethylene-mineral oil dispersion is prepared as described in U.S. Pat. No. 2,628,187. \n     (b) The SRF is blended with an equal weight of the dispersion of (a) in a planetary type mixer and then the material is passed through a roller mill. To 2 gm. of milled material is added 2 gm. of the dispersion (a) with mixing in a planetary type mixer until homogeneous. Again add (a) in an amount equal to that in the planetary mixer and mix until homogeneous. Continue this geometric addition process until the dispersion (a) has been completely utilized. \n     (c) The gelatin is introduced into the bowl of a planetary type mixer, covered with (b) and blended until homogeneous. \n     It is thus seen that I have provided a dentifrice which is eminently satisfactory to accomplish all of the aforesaid stated objectives.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["Cornea marker apparatus and a method of corneal marking are provided for purposes of corrective surgery. The apparatus features a blade assembly having readily visible blade ends as well as a blade assembly concept with a radial guide allowing rotation of the blades to selected meridian alignments for precise marking of the surface of the cornea."], "input": "TECHNICAL FIELD \n     This invention relates to eye surgery and more particularly to cornea marker apparatus and means of marking for corrective surgery such as radial and chordal refractive keratotomy (RK). \n     BACKGROUND ART \n     For the functional correction of eye disorders such as myopia and astigmatism due to abnormal curvature of the central clear zone of the cornea of the eye, a refractive keratotomy procedure provides benefit. In this procedure, for restoration of a flat clear zone, based on pre-operative patient selection and measurement of visual parameters such as corneal thickness, the cornea is first marked in a predetermined radially balanced pattern by making a circular cut (cf. U.S. Pat. No. 4,357,941) or a series of shallow incisions (cf. U.S. Pat. No. 4,417,579) in the annular corneal surface surrounding the clear zone. Visualization of the incisions is facilitated by delineation with a suitable dye such as fluorescein or gentian violet. The marking is done by free hand marking or preferably by a hand-held radial marker instrument of conventional spider-wheel design. One commercially available marker of this design is described in the work by Sanders et al. entitled &#34;Radial Keratotomy,&#34; pages 31 and 32, 1984, Slack Inc., Thorofare, N.J. \n     The marking procedure is then followed first by corneal thickness measurements (pachymetry) and then by making refractive incisions on the marked pattern of lines, using a diamond knife. \n     The prior art method of free hand marking often is unreliable whereas the method employing a spiderwheel marker tends to be unreliable in certain particulars. One problem, not generally recognized as important, is that the ends of each blade edge are not readily visible, and especially the inner end is not visible for purposes of centration and spacing from the clear zone. Another problem of the kind is that the marker lacks means for correctly and reliably aligning the marker to the corneal surface of an eye with astigmatism, for example, astigmatism with the rule where the vertical meridian has the greater curvature, or astigmatism against the rule where the horizontal meridian has the greater curvature, or irregular astigmatism due to uneven bulges, corneal scarring and the like. \n     It is therefore an object of the present invention to provide improved cornea marker apparatus having marker blades that are conspicuous for purposes of concentric placement and spacing from the central clear zone of the corneal surface. \n     It is another object of the invention to provide improved cornea marker apparatus having a marker blade assembly holder and a rotary blade assembly that can be controllably rotated in the holder to achieve correct placement for radially marking selected meridians of the corneal surface. \n     It is still another object of the invention to provide apparatus of the kind described in which the rotary blade assembly can be replaced in the holder with a different rotary blade assembly that may differ in shape, size, or radial orientation of the blades. \n     It is yet another object to provide improved methods for marking the corneal surface for purposes of corrective surgery. \n     These and other objects, features and advantages will be seen from the following description and accompanying drawings. \n     DISCLOSURE OF THE INVENTION \n     The invention in one preferred aspect concerns improved surgical apparatus for concentric placement on the cornea of the eye and for radially marking selected meridians of the corneal surface surrounding the central clear zone of the eye. The apparatus comprises a circumferential support frame having a central opening dimensioned for concentric alignment exposing the clear zone, and a pair of diametrically opposed co-planar radially disposed knife blades for each of said selected meridians. Each blade has a cutting edge with concave curvature adapted in 3-dimensioned blade assembly profile for co-extensive matching contact with the convex curvature of the outer corneal surface. Also, each blade is unitary with and supported on the support frame with its inner blade end projecting into the central opening whereby the blade inner ends are conspicuously exposed in the support frame opening for enabling precise placement of the blades in the corneal field. Preferably, the opening in the support frame is circular or elliptical. \n     In a preferred embodiment, the apparatus comprises a blade assembly holder and a rotary knife blade assembly. The holder has a central opening and a concentric circumferential bearing surface for engagement with the bearing surface of the rotary knife blade assembly. \n     The knife blade assembly includes a circumferential support frame having a central opening, preferably circular or elliptical, dimensioned for concentric alignment exposing the clear zone, and a pair of diametrically oppose co-planar radially disposed knife blades for each of the meridians selected for marking. Each blade has a cutting edge with concave curvature adapted in profile for co-extensive matching contract with the convex curvature of the outer corneal surface. Each blade is unitary with and supported on the support frame, the assembly being configured with a peripheral bearing surface adapted for engagement with said concentric bearing surface and allowing rotation with respect to the blade holder. Preferably, the inner end of each blade is conspicuously exposed in the support frame opening. Preferably, the knife blade assembly comprises blade guide indicia coinciding with the diametral alignment of each blade pair. \n     In a preferred embodiment, the blade holder comprises meridial indicia referable to the degree of rotation of a rotary knife blade assembly contained in the blade holder. In another preferred embodiment, the support frame is elliptical and the cutting edges of the blades of the knife blade assembly are configured with a 3-dimensional concave elliptical curvature for coextensive matching contact with the convex curvature of an ellipitcal astigmatic outer corneal surface. The blade assembly holder and the rotary blade assembly in a preferred embodiment are adapted to be removably fitted together, preferably in a snap fit, to a position for controlled rotation of the blade assembly to predetermined positions for marking of selected meridians. The holder and rotary blade assembly preferably are adapted to be disengageable for replacement of a different rotary blade assembly in the blade assembly holder. \n     The invention in another preferred aspect concerns an improved method for marking selected meridians of the outer corneal surface surrounding the open central zone of the cornea of the eye. The eye to be treated may be astigmatic, having greater curvature in a meridian that may be a vertical, horizontal, or other meridian. The method includes the step of providing a blade assembly holder with meridial indicia and a rotary knife blade assembly that is rotatable in the holder. The knife blade assembly has a marking surface substantially matching the outer corneal surface. The assembly has a predetermined pattern, circular or preferably elliptical, of opposed knife blade edges aligned in a pair for placement across the open corneal zone for each of the selected meridians. The method further comprises placing the knife blade edges of the marking surface in a selected meridian alignment with the corneal surface, and marking the cornea by knife edge cutting sufficient for visualization of the resulting meridial incisions. In a preferred embodiment, the blade assembly comprises blades having the curvature of about 47 diopters. \n    \n    \n     BRIEF DESCRIPTION OF THE DRAWINGS \n     The invention will be more fully understood by reference to the following detailed description and accompanying drawings in which: \n     FIG. 1 is a perspective view partly segmented of a preferred cornea marker according to the invention; \n     FIG. 2 is a cross-sectional view taken on line 2--2 of FIG. 1 showing the marker blade curvature in relation to curvature of the cornea of the eye; \n     FIG. 3 is an exploded view similar to the view of FIG. 1; \n     FIGS. 4 to 7 are plan views illustrating different preferred patterns of radially disposed paired marker blades of a cornea marker according to the invention; \n     FIG. 8 is a plan view of another preferred embodiment illustrating an elliptically disposed marker blade assembly with exposed inner and outer blade ends; \n     FIG. 9 is a side view of a blade assembly holder in section taken on line 9--9 of FIG. 8; \n     FIG. 10 is a side view of paired marker blades on a frame support partly in section taken on line 10--10 of FIG. 8; AND \n     FIG. 11 is a bottom view of the marker blade assembly of FIG. 8. \n    \n    \n     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS \n     In the embodiment of FIG. 1 a cornea marker 10 is shown with a marker blade assembly 30 having a blade support frame 30a in the form of an annular cap. As seen in FIG. 2, the frame or cap 30a carries on its underside a pattern or array of edge-mounted radially disposed knife blade pairs 32a and 32b. The frame has a central opening 31 with inner and outer edges 31a,31b. The frame also has a circumferential skirt 30b depending from its underside that together define a circumferential skirt groove 30c. The top side of the frame carries blade alignment indicia 30d. As seen in FIG. 2, the blades have a cutting edge 33 with concave curvature terminating at an inner end 34 and an outer end 35. In relation to the surface of the cornea 20 for purposes of marking, the cutting edges of the blade pair 32a,32b are located for concentric placement in co-extensive matching contact with the corneal surface. The inner edges 34 of the blades are spaced from the clear zone 21 while the outer edges 35 are spaced away from the corneal limbus 22. Also as seen in FIG. 2, the blade assembly is supported for rotation in a holder 40 having an annular base plate 41 carried for manipulation by a handle 42. The base plate has meridian indicia 46 on its upper face and has inner and outer edges 44,45 and the inner edge defining a circular opening and being configured for engagement with the skirt groove 30c, also circular. In a preferred embodiment, the two parts 30 and 40 are constructed such that they can be assembled together and disassembled (as shown in FIG. 3), as desired, preferably by means of a snap fit allowing relative rotation as between the two parts. When the blade assembly 30 is rotated, the same can be advanced to any desired position for marking by setting the blade alignment indicia 30d to coincide with the meridian indicia 46 requiring marking, such as the vertical (90\u00b0) meridian or the horizontal (0\u00b0 or 180\u00b0) meridian. Different patterns of marking can be achieved by using any of the different blade configurations shown in FIGS. 4 to 7. A preferred embodiment of the cornea marker is illustrated in FIG. 8. The blase assembly 30 has a circumferential groove 35a that is circular and the holder 40 has an inner edge 44 defining a matching central opening 43 so that when assembled the two parts can be rotated relative to each other. The blade assembly has an annular cap 30a that is elliptical with an elliptical central opening 31. The blade pairs are secured to the cap 30a by suitable means such as welding and are arranged with their inner and outer ends 34,35 open to view for precise placement and marking when held in the operative position shown in FIG. 8. \n     In operation, by marking methods which will be understood by those skilled in eye surgery, a blade assembly of the invention is selected that provides the most suitable pattern of marking for the particular surgical procedure, whether for correction of myopia, astigmatism or a combination of these. The appropriate blade assembly and the holder are assembled, and the assembly is rotated if necessary to the desired meridial alignment, for example the alignment shown in FIG. 8 for a marking pattern to correct for astigmatism. The marker is then placed in a marking position such as that shown in FIG. 2 (with the long axis blade pair on the horizontal meridian), and the corneal surface surrounding and adjacent to the clear zone is marked for purposes of pachymetry and refractive keratotomy. \n     What is desired to claim as my exclusive property in the invention, as described, is the following.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["Novel suppository pharmaceutical formulations of the platinum antitumor agent, JM216, are provided. Such dosage forms provide an alternative to the oral form currently available and offer improved bioavailability of this promising drug."], "input": "This application is a continuation of U.S. Ser. No. 09/017,912, filed Feb. 3, 1998, now abandoned, which claims the benefit of U.S. Provisional application Ser. No. 60/041,593, filed Mar. 17, 1997. \n    \n    \n     BACKGROUND OF THE INVENTION \n     1. Field of the Invention \n     The present invention relates to a novel method of increasing the aqueous solubility and bioavailability of the platinum antitumor complex, bis-acetato-ammine-dichloro-cyclohexylamine-platinum (IV), having the structural formula ##STR1## which will also be referred to below and in the claims by its literature codename, JM216. The invention also provides novel suppository dosage forms of JM216 adapted for rectal administration. \n     2. Description of the Prior Art \n     JM216 is an antitumor platinum (IV) complex presently undergoing clinical evaluation as an oral antitumor agent. The complex is described in U.S. Pat. Nos. 5,244,919 and 5,072,011. \n     Although the oral dosage form of JM216 being pursued in the clinic has obvious advantages over injectable platinum complexes such as cisplatin and carboplatin, it is reported by M. J. McKeage et al in Cancer Chemother. Pharmacol. 36: 451-458 (1995) that the current oral capsule form may have certain pharmacokinetic disadvantages. In a phase I clinical study C max  and AUC increased less than proportionally to dose at dose levels \u2267200 mg/m 2 . This was associated with greater interpatient pharmacokinetic variation and reduced urinary platinum recovery. Such pharmacokinetic variation and reduced gastro-intestinal drug absorption may be due to the poor water-solubility of JM216 which the present inventors have determined to be 0.3 mg/ml at 23\u00b0 C. \n     In addition to the bioavailability problems, there are important reasons why it is often preferred to administer a drug like JM216 rectally rather than orally, e.g. nausea, vomitting and stomach irritation associated with oral dosing, inability to swallow and the possibility of partly avoiding the hapatic first pass clearance. \n     SUMMARY OF THE INVENTION \n     This invention relates to a method of improving the aqueous solubility and thus absorption and bioavailability of JM216 pharmaceutical formulations, which comprises employing in said formulations amorphous JM216. The amorphous JM216 is obtained by grinding or milling JM216 powder with \u03b2-cyclodextrin or certain polymers for a sufficient period of time to convert the JM216 to an amorphous state, the polymer being preferably selected from gelatin, polyvinylpyrrolidinone (PVP) and hydroxypropylmethyl cellulose (HPMC). \n     In another aspect the invention relates to a suppository formulation for rectal administration comprising: \n     (a) JM216 \n     (b) a polyethylene glycol (PEG) suppository base, and \n     (c) a fatty acid selected from caproic acid or its sodium salt, caprylic acid or its sodium salt and the sodium salt of oleic acid. \n     The suppository formulation of the present invention may optionally contain a surface active agent and the JM216 may be employed in an amorphous state obtained by grinding or milling JM216 powder with \u03b2-cyclodextrin or a polymer selected from gelatin, polyvinylpyrrolidinone and hydroxypropylmethyl cellulose. \n     DETAILED DESCRIPTION OF THE INVENTION \n     JM216 is a platinum antitumor complex having poor water-solubility. This low solubility may be associated with bioavailability problems seen in a recent phase I clinical study where the compound was orally administered in the form of hard gelatin capsules with excipients (microcrystalline cellulose, sodium starch glycolate, lactose anhydrous and magnesium stearate). \n     It was an object of the present invention to find a way of increasing the aqueous solubility of JM216 so as to improve the bioavailability of the compound and perhaps also eliminate or reduce side effects seen with oral dosing such as nausea and vomitting. It was another object of the invention to develop a suppository dosage formulation of JM216 which could provide the same therapeutic advantages of the existing oral formulation while also improving the bioavailability. It was hoped that the suppository formulation would also have an improved side-effect profile as well as being an alternate dosage form for those patients who cannot tolerate oral dosing, e.g. infant patients or patients with disorders of the digestive organs. \n     The present inventors first attempted to reduce the particle size of the JM216 powder obtained from chemical synthesis by grinding or milling it to an amorphous state (as confirmed by x-ray diffraction pattern). The amorphous state indicates the disappearance of particles or crystalline drug and a particle size close to the molecular level. However, it was found to be very difficult to obtain an amorphous state by simply grinding the drug alone owing to the re-aggregation of drug powder by electrostatic force during the grinding process. The addition of \u03b2-cyclodextrin or polymers to the JM216 during the grinding did allow obtaining the drug as an amorphous powder by reduction of the aggregation. Interestingly, the effect on solubility was quite dependent on the polymer used, with gelatin, polyvinylpyrrolidinone and hydroxypropylmethyl cellulose showing marked improvement of dissolution rate over drug alone. The ratio of drug:\u03b2-cyclodextrin or drug:polymer also has some effect on solubility, with solubility generally increasing at higher \u03b2-cyclodextrin:drug or polymer:drug ratios. Ratios of drug:\u03b2-cyclodextrin or drug:polymer of from about 1:1 to about 1:15 (w/w) can be used with ratios of from about 1:4 to 1:15 being preferred and ratios of from about 1:9 to about 1:15 being most preferred. Table I below shows dissolution results when various JM216:polymer or JM216:\u03b2-cyclodextrin mixtures, after grinding with an automatic mortar for three hours, were evaluated in a standard dissolution test. \n     \n                       TABLE 1______________________________________Dissolution of JM216      Dissolved JM216 (mg/ml)      1 Min.            5 Min.  15 Min. 30 Min.                                  60 Min.______________________________________JM216 bulk drug alone        0.2     0.3     0.5   0.5   0.5JM216:gelatin (1:9, w/w)        1.4     1.2     1.2   1.1   1.1JM216:gelatin (1:4, w/w)        1.1     1.1     1.0   0.9   1.0JM216:gelatin (1:1, w/w)        0.5     0.6     0.7   0.7   0.6JM216:HPMC (1:9, w/w)        0.9     1.1     1.0   0.9   0.9JM216:HPMC (1:4, w/w)        0.7     0.8     0.7   0.7   0.7JM216:HPMC (1:1, w/w)        0.6     0.7     0.6   0.6   0.6JM216:PVP (1:9, w/w)        0.8     0.9     1.0   0.9   0.9JM216:Pullulan        0.5     0.8     0.7   0.7   0.7(1:9, w/w)JM216:PEG 6000        0.5     0.5     0.5   0.5   0.5(1:9, w/w)JM216:Avicel (1:9, w/w)        0.7     0.7     0.7   0.7   0.7JM216:Lactose        0.7     0.7     0.7   0.7   0.7(1:9, w/w)JM216:\u03b2-cyclodextrin        0.9     0.9     0.9   0.9   0.9(1:9, w/w)______________________________________ HPMC = hydroxypropylmethyl cellulose, PVP = polyvinylpyrrolidone, PEG = polyethylene glycol, Pullulan = natural polysaccharide, Avicel is the tradename of FMC Corporation for microcrystalline cellulose \n    \n     Dissolution test: The ground mixture containing 5 mg. of JM216 was transferred directly into 50 ml of phosphate buffer (1/15 M, pH 7.5) kept at 37\u00b0 C. and was stirred with a magnetic stirrer bar at 300 rpm. An aliquot of the solution was pipetted at the indicated time intervals and filtered through a 0.45 \u03bcm membrane filter. The concentration of the dissolved JM216 was determined by high performance liquid chromatography (HPLC). \n     Grinding of the JM216:\u03b2-cyclodextrin or JM216:polymer mixtures may be accomplished by standard procedures, e.g. automatic mortar and pestle machines or a hybridizer (milling machine). The time needed in the grinding process may be readily determined by simple test (period analysis of the mixture by x-ray diffraction studies). A suitable grinding time with the automatic mortar and pestle machine is three hours and with the hybridizer, five minutes. \n     As can be seen from Table I, use of amorphous JM216 with \u03b2-cyclodextrin or certain polymer additives significantly increases the water-solubility of JM216. The preferred formulations with increased solubility are those where the JM216 is ground to an amorphous state in the following drug:\u03b2-cyclodextrin or drug:polymer ratios: \n     JM216:gelatin in ratios of from about 1:4 to about 1:9 (w/w); \n     JM216:HPMC in a 1:9 (w/w) ratio; \n     JM216:PVP in a 1:9 (w/w) ratio; and \n     JM216:\u03b2-cyclodextrin in a 1:9 (w/w) ratio. \n     Such formulations result in approximately a doubling of the aqueous solubility over bulk JM216 powder alone and are one important aspect of the present invention. Such amorphous JM216 can be used in a wide variety of JM216 pharmaceutical formulations, including both oral and non-oral forms, to improve the bioavailability of JM216. \n     The present inventors also explored developing a suppository dosage form of JM216 which would provide an alternative dosage form for those patients unable to use the current oral capsules. It was a goal to develop such a suppository dosage form which would have better absorption than the oral form and reduced side effects, e.g. nausea and vomitting. \n     In their studies in vitro drug absorption of the test formulations was examined using excised rat rectum in accordance with the method described by T. Ogiso et al in J. Pharmacobio-Dyn., 14, 385 (1991). The rectum was freshly excised from each rat and was opened lengthwise using scissors. The excised rectum, serous membrane side down, was mounted on a Franz diffusion cell (reservoir volume 10 ml, 7 mm i.d. O ring flange). Each preparation (80 mg., 2 mg as JM216) was uniformly applied to the mucosal side and was occluded with a sheet of aluminum foil. Gentamicin solution (10 mg/ml) was added to the reservoir fluid (phosphate buffer, pH 7.3) in the ratio of 1:100. The assembly was incubated at 37\u00b0 C. and aliquots (200 (\u03bcl) of the reservoir fluid were periodically withdrawn for 23 hours. The amount of JM216 permeated through rat rectum was determined by HPLC. \n     The various test samples were incorporated into standard suppository bases and then subjected to the in vitro drug absorption test. In addition, JM 216 powder alone and the ground anhydrous JM216:\u03b2-cyclodextrin or JM216:polymer mixture suspended in water were also subjected to the tests. The suppository samples were prepared by fusion method melting the base at 50\u00b0 C. for fatty bases or at 75\u00b0 C. for polyethylene glycol water-soluble base. The drug was incorporated into the base at a concentration of 2 mg/80 mg base. Medium chain fatty acids (or Na salts thereof) and surface active agents were also added at the appropriate level. \n     The results in the rat rectum absorption model are as shown below in Table II. \n     \n                                           TABLE II__________________________________________________________________________JM216 ABSORPTION THROUGH EXCISED RAT RECTUM            Suppository                    JM216 Absorbed (%)Drug     Additives            Bases   14 h                       17 h                          20 h                             23 h__________________________________________________________________________JM216            Water   0.0                       0.0                          0.0                             0.0(non-amorphous)JM216            Witepsol H-15                    0.0                       0.0                          0.0                             0.0(non-amorphous)JM216            Pharmasol                    0.0                       0.0                          0.0                             0.0(non-amorphous)JM216            Isocacao                    0.0                       0.0                          0.0                             0.2(non-amorphous)JM216            Miglyol 0.0                       0.0                          0.0                             0.0(non-amorphous)JM216            PEG     0.2                       0.5                          0.9                             1.2(non-amorphous)JM216            PEG + Pharmasol                    0.0                       0.0                          0.0                             0.3(non-amorphous)JM216    3%, capryl-Na            PEG     7.5                       8.6                          10.5                             11.5(non-amorphous)JM216    3%, BL-21            PEG     1.8                       4.6                          5.2                             6.2(non-amorphous)JM216    3%, BLYK            PEG     0.6                       1.1                          1.3                             3.7(non-amorphous)JM216    3%, BL-21            Pharmasol                    0.1                       0.3                          0.6                             0.8(non-amorphous)JM216    3%, GLYK            Pharmasol                    0.0                       0.0                          0.1                             0.3(non-amorphous)JM216:gelatin (1:9)            Water   0.0                       0.0                          0.1                             0.3JM216:gelatin (1:9)            PEG     0.2                       0.6                          1.8                             3.8JM216:gelatin (1:9)            Pharmasol                    0.0                       0.0                          0.1                             0.3JM216:gelatin (1:9)            Miglyol 0.0                       0.0                          0.2                             0.7JM216:gelatin (1:9)    3%, caproic            PEG     1.8                       2.8                          3.6                             5.0    acidJM216:gelatin (1:9)    3%, caprylic            PEG     5.2                       6.5                          7.9                             9.4    acidJM216:gelatin (1:9)    3%, capric            PEG     1.2                       1.8                          2.9                             4.1    acidJM216:gelatin (1:9)    3%, oleic            PEG     0.7                       1.4                          2.2                             3.2    acidJM216:gelatin (1:9)    3%, linoleic            PEG     0.8                       1.4                          2.2                             3.3    acidJM216:gelatin (1:9)    3%, linolenic            PEG     0.2                       0.6                          1.2                             1.8    acidJM216:gelatin (1:9)    3%, caproic-            PEG     5.9                       9.5                          11.3                             14.6    NaJM216:gelatin (1:9)    3%, capric-Na            PEG     2.4                       3.6                          4.3                             6.4JM216:gelatin (1:9)    3%, lauric-Na            PEG     1.5                       2.2                          3.4                             4.9JM216:gelatin (1:9)    3%, oleic-Na            PEG     2.0                       3.1                          3.5                             5.3JM216:gelatin (1:9)    3%, capryl-Na            miglyol 0.1                       0.2                          0.4                             0.8JM216:gelatin (1:9)    3%, capryl-Na            PEG + miglyol*                    2.5                       3.7                          4.8                             6.1JM216:gelatin (1:9)    1%, capryl-Na            PEG     3.8                       5.3                          6.5                             7.5JM216:gelatin (1:9)    3%, capryl-Na            PEG     7.0                       9.0                          10.8                             13.2JM216:gelatin (1:9)    7%, capryl-Na            PEG     2.3                       3.0                          4.0                             4.8JM216:gelatin (1:9)    3%, GLYK            PEG     0.1                       0.7                          1.3                             1.9JM216:gelatin (1:9)    3%, pluronic            PEG     0.3                       0.5                          0.8                             1.2JM216:gelatin (1:9)    3%, capryl-NaJM216:gelatin (1:9)    +3%, pluronic            PEG     6.6                       8.6                          10.1                             11.1JM216:gelatin (1:9)    3%, capryl-Na            PEG     5.7                       7.4                          8.8                             9.5    +3%, Tween 80JM216:gelatin (1:9)    3%, capryl-Na            PEG     1.5                       2.5                          3.2                             4.3    +3%m BL-21JM216:\u03b2-    3%, capryl-Na            PEG     0.3                       0.8                          1.6                             2.0cyclodextrin (1:9)JM216:\u03b2    3%, pluronic            PEG     1.1                       2.0                          2.7                             3.2cyclodextrin (1:9)JM216:HPMC (1:9)    3%, capryl-Na            PEG     1.5                       2.1                          3.7                             4.3__________________________________________________________________________ *Miglyol was used here as an additive to change the nature of the PEG suppository base. The base gradually dissolves in water because of the addition of Miglyol. It is prepared by adding 3-10% of Miglyol to PEG at 75\u00b0 C. mixing (stirring) with 1-5% pluronic F68. The actual formulation of base used here was PEG + 3% pluronic F68 + 5% Miglyol. Tween 80 could be substituted for the pluronic F68. Witepsol H15 = fatty suppository base manufactured by Huls Aktiengesellsc Pharmasol = fatty suppository base manufactured by Nippon Oil &amp; FAts Co., Ltd. Isocacao = fatty suppository base manufactured by Kao Co. Miglyol = Medium chain fatty acid triglyceride suppository base manufactured by Huls Aktiengesellsch PEG = Polyethylene glycol (watersoluble suppository base) CaprylNa = Sodium caprylate (fatty acid) BL21 = Polyoxyethylene (21) lauryl ether (surface active agent) GLYK = Dipotassium glycyrrhizinate (surface active agent) Caproic acid (fatty acid) Caprylic acid (fatty acid) Capric acid (fatty acid) Oleic acid (fatty acid) Linoleic acid (fatty acid) Linolenic acid (fatty acid) CapricNa = sodium caprate (fatty acid) LauricNa = sodium laurate (fatty acid) OleicNa = sodium oleate (fatty acid) CaproicNa = sodium caproate (fatty acid) Pluronic = F68 (poloxamer) (surface active agent) Tween 80 = polysorbate 80 = a surface active agent \n    \n     Looking at the results of this study, JM216 bulk drug (non-amorphous) was little absorbed in the form of a suspension in water or in fatty suppository bases. The drug alone was, however, absorbed to some extent when incorporated into the water-soluble base, polyethylene glycol (PEG). PEG was thus determined to be the most appropriate suppository base for JM216. PEG having molecular weights of from about 400-6000 is preferred (the PEG used in the above study was a mixture of 400, 1500 and 4000 (2:1:5, w/w) molecular weight material). \n     Based on their experience, the present inventors determined that in the rat rectum absorption model a percentage absorption of 4% or greater was considered necessary for a commercially useful suppository formulation of JM216. \n     Addition of certain fatty acids to the PEG suppository base containing non-amorphous JM216 gave the desired absorption levels while similar PEG formulations without these fatty acids were unacceptable. The amorphous JM216 produced by grinding or milling JM216 with \u03b2-cyclodextrin or polymers, particularly gelatin, HPMC or PVP, can also be added to a PEG suppository base and certain fatty acids, particulary caproic acid or its sodium salt, caprylic acid or its sodium salt, capric acid or its sodium salt and the sodium salt of oleic acid, to obtain a suppository dosage form having excellent absorption properties. The fatty acid is used in an amount of from 0.5 to 10% (w/w) of the total suppository weight. \n     Addition of surface active agents to the suppositories employing a PEG base, amorphous JM216 and a fatty acid selected from caproic acid or its sodium salt, caprylic acid or its sodium salt, capric acid or its sodium salt and the sodium salt of oleic acid also resulted in suppository formulations showing high absorption. Again, in the case of amorphous JM216, material made by grinding JM216 with gelatin, HPMC, PVP or \u03b2-cyclodextrin, is preferred for achieving the best absorption results. The surface active agent is employed in an amount of from 0.5 to 7% of the total suppository weight. Preferred surface active agents include Tween 80 and pluronic (e.g. pluronic F68). \n     The JM216, whether amorphous or non-amorphous, is used in an amount of from 0.1 to 10% (w/w) of the total suppository weight. \n     Particularly preferred suppository formulations according to the present invention include the following: \n     JM216:gelatin (1:9, w/w), PEG suppository base, 3% capryl Na \n     JM216:gelatin (1:9, w/w), PEG suppository base, 3% capryl Na, 3% pluronic surface active agent \n     JM216:gelatin (1:9, w/w), PEG suppository base, 3% capryl Na, 3% Tween 80 surface active agent \n     JM216:gelatin (1:9, w/w), PEG suppository base, 3% caproic Na \n     JM216:gelatin (1:9, w/w), PEG suppository base, 3% caprylic acid \n     JM216 (non-amorphous), PEG suppository base, 3% capryl Na \n     The suppository formulations are prepared by mixing of the JM216 and fatty acid with a PEG suppository base by any recognized method of making suppositories using water-soluble PEG bases. The surface active agents and other excipients such as Miglyol can also be added to the mixture. The dosage amount of JM216 in the suppository formulation is sufficient to insure the release of sufficient dosage units of JM216 into the blood to provide the desired therapeutic effect and may be readily determined by those skilled in the art by simple test. \n    \n    \n     EXAMPLES \n     Example 1 \n     Preparation of JM216 suppository using sodium salt of fatty acid \n     Formulation: JM216:gelatin (1:9, w/w)+3% caproic-Na+PEG \n     PEG400, PEG1500 and PEG6000 were mixed in a ratio of 2:1:5 (w/w) and then melted at 75\u00b0 C. The ground mixture (20 g) of JM216 and gelatin (1:9, w/w) was added to the melted PEG mixture (57.6 g) and stirred until the ground mixture was dispersed homogeneously. Sodium caproate (2.4 g) was added and then stirred for a short time at 70\u00b0 C. The mass was immediately poured into molds and allowed to solidify at room temperature. The above process was carried out in a light-free environment. \n     Example 2 \n     Preparation of JM216 suppository using free fatty acid \n     Formulation: JM216:gelatin (1:9, w/w)+3% caprylic acid+PEG \n     PEG400, PEG1500 and PEG6000 were mixed in a ratio of 2:1:5 (w/w) and then melted at 75\u00b0 C. The ground mixture (20 g) of JM216 and gelatin (1:9, w/w) was added to the melted PEG mixture (57.6 g) and stirred until the ground mixture was dispersed homogeneously. Caprylic acid (2.4 g) was added and then stirred for a short time at 70\u00b0 C. The mass was immediately poured into molds and allowed to solidify at room temperature. The entire process was carried out in a light-free environment. \n     Example 3 \n     Preparation of JM216 suppository using surface active agent \n     Formulation: JM216:gelatin (1:9, w/w)+3% capryl-Na+3% pluronic F68+PEG \n     PEG400, PEG1500 and PEG6000 were mixed in a ratio of 2:1:5 (w/w) and then melted at 75\u00b0 C. Pluronic F68 (2.4 g) was added to the melted PEG mixture (55.2 g) and stirred vigorously. The ground mixture (20 g) of JM216 and gelatin (1:9, w/w) was added to the mixture and stirred until the ground mixture was dispersed homogeneously. Sodium caprylate (2.4 g) was added and then stirred for a short time at 70\u00b0 C. The mass was immediately poured into molds and allowed to solidify at room temperature. The entire process was carried out in a light-free environment.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["Dough with a high sucrose content (such as cake dough) tends to inhibit the activity of an anti-staling amylase such as Novamyl, making it less effective to prevent the staling of dough-based products with high sucrose content such as cakes. A good anti-staling effect in cakes can be achieved by using a carefully selected anti-staling amylase with certain properties.  Analysis of a 3D structure of Novamyl shows that sucrose may inhibit by binding in the active site. Sucrose docks into the active site of Novamyl differently from the substrate or inhibitor in published models 1QHO and 1QHP. This finding is used to design sucrose-tolerant variants."], "input": "CROSS-REFERENCE TO RELATED APPLICATIONS \n       [0001]    This application is a divisional of U.S. application Ser. No. 11/575,644 filed on Mar. 20, 2007 which is a 35 U.S.C. 371 national application of PCT/DK2005/000602 filed Sep. 23, 2005, which claims priority or the benefit under 35 U.S.C. 119 of Danish application no. PA 2004 01458 filed Sep. 24, 2004 and U.S. provisional application No. 60/614,826 filed Sep. 30, 2004, the contents of which are fully incorporated herein by reference. \n     \n    \n     SEQUENCE LISTING AND DEPOSITED MICROORGANISMS \n     Sequence Listing \n       [0002]    The present invention comprises a sequence listing. \n       Deposit of Biological Material \n       [0003]    None. \n       FIELD OF THE INVENTION \n       [0004]    The present invention relates to the use of anti-staling amylases in the preparation of dough or dough-based edible products with a high sucrose content. \n       BACKGROUND OF THE INVENTION \n       [0005]    U.S. Pat. No. 3,026,205 describes a process of producing baked confections and the products resulting therefrom by alpha-amylase. \n         [0006]    WO 9104669 describes the use of a maltogenic alpha-amylase to retard the staling of baked products such as bread; the maltogenic alpha-amylase described therein is commercially available under the tradename Novamyl\u00ae (product of Novozymes A/S). U.S. Pat. No. 6,162,628 describes Novamyl variants and their use for the same purpose. Three-dimensional structures of Novamyl are published in U.S. Pat. No. 6,162,628 and in the Protein Data Bank (available at http://www.rcsb.org/pdb/) with identifiers 1QHO and 1QHP. \n       SUMMARY OF THE INVENTION \n       [0007]    The inventors have found that a high sucrose content dough (such as cake dough) tends to inhibit the activity of an anti-staling amylases such as Novamyl, making it less effective to prevent the staling of dough-based products with high sucrose content such as cakes. They have found that a good anti-staling effect in cakes can be achieved by using a carefully selected anti-staling amylase with certain properties, and they have identified such amylases. \n         [0008]    By analyzing a 3D structure of Novamyl, the inventors further found that sucrose may inhibit by binding in the active site. They have found that sucrose docks into the active site of Novamyl differently from the substrate or inhibitor in published models 1QHO and 1QHP, and they have used this finding to design sucrose-tolerant variants. \n         [0009]    Accordingly, the invention provides a method of preparing dough or a dough-based edible product (e.g. a baked product) by adding a sucrose-tolerant anti-staling amylase. It also provides novel sucrose tolerant variants of a maltogenic alpha-amylase. \n     \n    \n     \n       BRIEF DESCRIPTION OF THE DRAWINGS \n         [0010]      FIG. 1  shows the cartesian coordinates for the sucrose atoms in this binding configuration, using the coordinate system of the x-ray structure 1QHO.pdb. \n       \n    \n    \n     DETAILED DESCRIPTION OF THE INVENTION \n     Maltogenic Alpha-Amylase and Sucrose Docking \n       [0011]    A maltogenic alpha-amylase (EC 3.2.1.133) having more than 70% identity (particularly more than 80% or 90%, such as at least 95% or 96% or 97% or 98% or 99%) with the Novamyl sequence shown as SEQ ID NO: 1 may be used as the parent enzyme for designing sucrose tolerant variants. Amino acid identity may be calculated as described in U.S. Pat. No. 6,162,628. \n         [0012]    For Novamyl (SEQ ID NO: 1), a 3D structure including a substrate or inhibitor as described in U.S. Pat. No. 6,162,628 or in the Protein Data Bank with the identifier 1QHO or 1QHP may be used. Alternatively, a Novamyl variant may be used, such as a variant described in U.S. Pat. No. 6,162,628 or in this specification, e.g. the variant F188L+D261G+T288P. A 3D structure of a variant may be developed from the Novamyl structure by known methods, e.g. as described in T. L. Blundell et al., Nature, vol. 326, p. 347 ff (26 Mar. 1987); J. Greer, Proteins: Structure, Function and Genetics, 7:317-334 (1990); or Example 1 of WO 9623874. \n         [0013]    The inventors found that sucrose may inhibit Novamyl by binding in the active site. Docking of sucrose into the active site of Novamyl (using the software GOLD version 2.1.2, Cambridge Crystallographic Data Centre, 12 Union Road, Cambridge, CB2 1EZ, UK and the protein part of the x-ray structure 1QHO.pdb) reveals a specific binding configuration as unique to sucrose. The cartesian coordinates for the sucrose atoms in this binding configuration, using the coordinate system of the x-ray structure 1QHO.pdb are given in  FIG. 1 . \n       Maltogenic Alpha-Amylase Assay \n       [0014]    The activity of a maltogenic alpha-amylase may be determined using an activity assay such as the MANU method. One MANU (Maltogenic Amylase Novo Unit) is defined as the amount of enzyme required to release one micro-mole of maltose per minute at a concentration of 10 mg of maltotriose substrate per ml in 0.1 M citrate buffer at pH 5.0, 37\u00b0 C. for 30 minutes. \n       Amino Acid Alterations \n       [0015]    The amino acid sequence of a maltogenic alpha-amylase may be altered to decrease the sucrose inhibition. The inventors found that the alteration may be made at an amino acid residue having at least one atom within 4 \u212bngstroms from any of the sucrose atoms when the sucrose molecule is docked in the 3D structure of the maltogenic alpha-amylase. Using the Novamyl structure 1QHO and the sucrose docking in  FIG. 1 , the following Novamyl residues are within 4 \u212b: K44, N86, Y89, H90, Y92, W93, F188, T189, D190, P191, A192, F194, D372, P373, R376. \n         [0016]    Further the following positions have been identified as relevant: I15, R81, T87, G88, L196, N371 or N375 of SEQ ID NO: 1. \n         [0017]    The alteration may be a substitution or deletion of one or more of the selected residues, or one or more residues (particularly 1-4 residues or 5-6 residues) can be inserted adjacent to a selected residue. \n         [0018]    The substitution may be with a smaller or larger residue. A substitution to increase the size of the residue may diminish the space obtained by the docked sucrose molecule thereby preventing the binding of sucrose. Amino acid residues are ranked as follows from smallest to largest: (an equal sign indicates residues with sizes that are practically indistinguishable): \n         [0000]    \n       \n      \n       G&lt;A=S=C&lt;V=T&lt;P&lt;L=I=N=D=M&lt;E=Q&lt;K&lt;H&lt;R&lt;F&lt;Y&lt;W  \n      \n     \n         [0019]    The substitution may also be such as to eliminate contacts with the sucrose molecule, in particular by moving or removing potential sites of hydrogen bonding or Van der Waals interactions. \n         [0020]    The substitution may particularly be with another residue of the same type where the type is negative, positive, hydrophobic or hydrophilic. The negative residues are D,E, the positive residues are K/R, the hydrophobic residues are A,C,F,G,I,L,M,P,V,W,Y, and the hydrophilic residues are H,N,Q,S,T. \n         [0021]    Some particular examples of substitutions are I15T/S/V/L, R18K, K44R/S/T/Q/N, N86Q/S/T, T87N/Q/S, G88A/S/T, Y89W/F/H, H90W/FN/R/K/N/Q/M, W93Y/F/M/E/G/V/T/S, F188H/L/I/T/G/V, D190E/Q/G, A192S/T, F194S/LN, L196F, N371K/R/FN/Q, D372E/Q/S/T/A and N375S/T/D/E/Q. \n         [0022]    Examples of deletions are deletion of residue 191 or 192. An example of an insertion is Ala inserted between 192 and 193. \n         [0023]    The polypeptide may include other alterations compared to Novamyl (SEQ ID NO: 1), e.g. alterations to increase the thermostability as described in U.S. Pat. No. 6,162,628. \n       Nomenclature for Amino Acid Alterations \n       [0024]    In this specification, an amino acid substitution is described by use of one-letter codes, e.g. K44R. Slashes are used to indicate alternatives, e.g. K44R/S/T/Q/N to indicate substitution of K44 with R or S etc. P191* indicates a deletion of P191. *192aA indicates insertion of one Ala after A192. Commas are used to indicate multiple alterations in the sequence, e.g. F188L,D261G,T288P to indicate a variant with three substitutions. \n         [0000]    Properties of Anti-Staling Amylase for Use with Sucrose \n         [0025]    The amylase for use in high-sucrose dough may be selected so as to have mainly exo-amylase activity. More specifically, the amylase hydrolyzes amylose so that the average molecular weight of the amylose after 0.4-4% hydrolysis is more than 50% (particularly more than 75%) of the molecular weight before the hydrolysis. \n         [0026]    Thus, the amylase may hydrolyze amylose (e.g. wheat amylose or synthetic amylose) so that the average molecular weight of the amylose after 0.4-4% hydrolysis (i.e. between 0.4-4% hydrolysis of the total number of bonds) is more than 50% (particularly more than 75%) of the value before the hydrolysis. The hydrolysis can be conducted in a 1.7% amylose solution by weight at suitable conditions (e.g. 10 minutes at 60\u00b0 C., pH 5.5), and the molecular weight distribution before and after the hydrolysis can be determined by HPLC. The test may be carried out as described in C. Christophersen et al., Starch 50 (1), 39-45 (1998). \n         [0027]    An exo-amylase for use in high-sucrose dough may have a specified sugar tolerance. Compared to its activity in the absence of sucrose, the amylase may have more than 20% activity at 10% sugar, more than 10% activity at 20% sucrose, or more than 4% activity at 40% sucrose. The sugar tolerance may be determined as described in the examples. \n         [0028]    The exo-amylase may have optimum activity in the pH range 4.5-8.5. It may have sufficient thermostability to retain at least 20% (particularly at least 40%) activity after 30 minutes incubation at 85\u00b0 C. at pH 5.7 (50 mM Na-acetate, 1 mM CaCl 2 ) without substrate. \n         [0029]    The exo-amylase may be added to the dough in an amount corresponding to 1-100 mg enzyme protein per kg of flour, particularly 5-50 mg per kg. \n         [0030]    The exo-amylase may be non-liquefying. This can be determined by letting the exo-amylase act on a 1% wheat starch solution until the reaction is complete, i.e. addition of fresh enzyme causes no further degradation, and analyzing the reaction products, e.g. by HPLC. Typical reaction conditions are e.g. 0.01 mg enzyme per ml starch solution for 48 hours. The exo-amylase is considered non-liquefying if the amount of residual starch after the reaction is at least 20% of the initial amount of starch. \n         [0031]    The exo-amylase may have maltogenic alpha-amylase activity (EC 3.2.1.133). The exo-amylase may be the amylase described in DK PA 2004 00021, or it may be a Novamyl variant described in this specification. \n       Dough and Dough-Based Edible Product \n       [0032]    The dough may have a sucrose content above 10% by weight, particularly above 20% or 30%, e.g. 30-40%. The flour content is typically 25-35% by weight of total ingredients. The dough may be made by a conventional cake recipe, typically with cake flour, sugar, fat/oil and eggs as the major ingredients. It may include other conventional ingredients such as emulsifiers, humectants, gums, starch and baking powder. It generally contains such ingredients as soft wheat flour, milk or other liquids, sugar, eggs, chemical leaveners, flavor extracts and spices, as well as others that may or may not include shortening. \n         [0033]    The dough is generally heat treated, e.g. by baking or deep frying to prepare an edible product such as cakes including pound cake, yellow and white layer cakes, cakes containing chocolate and cocoa products, sponge cakes, angel food cake, fruit cakes and foam-type cakes and doughnuts. \n       EXAMPLES \n     Example 1 \n     Sucrose Tolerance of Novamyl Variants \n       [0034]    The amylase activity of a number of polypeptides were tested by incubation with Phadebas tablets (product of Pharmacia\u00ae) for 15 minutes at 60\u00b0 C. in the presence of sucrose at various concentrations (in % by weight). The results are expressed in % of the result without sugar: \n         [0000]    \n       \n         \n               \n               \n               \n               \n               \n             \n               \n               \n               \n               \n               \n             \n           \n               \n                   \n               \n               \n                 Alterations compared to \n                 0% \n                   \n                 20% \n                   \n               \n               \n                 SEQ ID NO: 1 \n                 sucrose \n                 10% sucrose \n                 sucrose \n                 40% sucrose \n               \n               \n                   \n               \n             \n             \n               \n                   \n               \n             \n          \n           \n               \n                 None \n                 100 \n                 13 \n                 6 \n                 1.5 \n               \n               \n                 F188L, D261G, T288P \n                 100 \n                 27.5 \n                 14.5 \n                 6 \n               \n               \n                 F194S \n                 100 \n                 31.5 \n                 18.5 \n                 7.5 \n               \n               \n                 L196F \n                 100 \n                 69 \n                 42 \n                 23 \n               \n               \n                 D190G \n                 100 \n                 65 \n                 43 \n                 21 \n               \n               \n                   \n               \n             \n          \n         \n       \n     \n       Example 2 \n     Sucrose Tolerance of Novamyl Variants \n       [0035]    A number of polypeptides were tested as in Example 1. The results are expressed as activity with 10% sucrose in % of the activity without sucrose: \n         [0000]    \n       \n         \n               \n               \n               \n             \n           \n               \n                   \n                   \n               \n               \n                   \n                   \n                 Sugar \n               \n               \n                   \n                 Alterations compared to SEQ ID NO: 1 \n                 tolerance \n               \n               \n                   \n                   \n               \n             \n             \n               \n                   \n                 None \n                 15 \n               \n               \n                   \n                 D261G, T288P \n                 24 \n               \n               \n                   \n                 F188L, D261G, T288P \n                 35 \n               \n               \n                   \n                 T288P \n                 56 \n               \n               \n                   \n                 Y89F, D261G, T288P \n                 42 \n               \n               \n                   \n                 N86V, F188L, D261G, T288P \n                 37 \n               \n               \n                   \n                 Y89F, F188L, D261G, T288P \n                 38 \n               \n               \n                   \n                 Y89H, F188L, D261G, T288P \n                 50 \n               \n               \n                   \n                 N86T, F188L, D261G, T288P \n                 49 \n               \n               \n                   \n                 F194S, D261G, T288P \n                 47 \n               \n               \n                   \n                 L196F \n                 65 \n               \n               \n                   \n                 D261G, T288P, D372V \n                 62 \n               \n               \n                   \n                 Q184H, N187D, F194Y \n                 47 \n               \n               \n                   \n                 D190G \n                 66 \n               \n               \n                   \n                 N86G, Y89M, F188L, D261G, T288P \n                 47 \n               \n               \n                   \n                 F188L, D190G, D261G, T288P \n                 68 \n               \n               \n                   \n                 A192Q, D261G, T288P, S446A \n                 46 \n               \n               \n                   \n                 F188H \n                 49 \n               \n               \n                   \n                 P191* \n                 42 \n               \n               \n                   \n                 A192* \n                 51 \n               \n               \n                   \n                 A192*, G193* \n                 67 \n               \n               \n                   \n                 *192aA \n                 44 \n               \n               \n                   \n                 N86K, F252L, D261G, T288P \n                 49 \n               \n               \n                   \n                 F194Y, L225S, D261G, T288P \n                 49 \n               \n               \n                   \n                 F194L, D261G, T288P \n                 54 \n               \n               \n                   \n                 F194S, D261G, T288P, P642Q \n                 60 \n               \n               \n                   \n                 D261G, T288P, N375S \n                 58 \n               \n               \n                   \n                 F188T \n                 37 \n               \n               \n                   \n                 F188G \n                 36 \n               \n               \n                   \n                 F188V \n                 41 \n               \n               \n                   \n                 A192R, F194L, D261G, T288P, G469R \n                 60 \n               \n               \n                   \n                 A192G, D261G, T288P \n                 41 \n               \n               \n                   \n                 Y89F, D261G, T288P, I290V, N375S \n                 60 \n               \n               \n                   \n                   \n               \n             \n          \n         \n       \n     \n         [0036]    The following variants are also considered of interest in the context of the present invention: \n         [0000]    \n       \n         \n               \n             \n               \n               \n             \n           \n               \n                   \n               \n               \n                 Alterations compared to SEQ ID NO: 1 \n               \n               \n                   \n               \n             \n             \n               \n                   \n               \n             \n          \n           \n               \n                   \n                 I15T, N86K, P191S, D261G, T288P \n               \n               \n                   \n                 I15T, P191S, D261G, T288P \n               \n               \n                   \n                 I15T, P191S, Y258F, D261G, T288P, N375S, Y549C, Q648H \n               \n               \n                   \n                 I15T, G153R, P191S, D261G, T288P, N371K, K645R \n               \n               \n                   \n                   \n               \n             \n          \n         \n       \n     \n       Example 3 \n     Sucrose Tolerance and Thermostability of Amylases \n       [0037]    The following amylases were tested for thermostability and sugar tolerance: bacterial alpha-amylase from  B. amyloliquefaciens  (BAN\u2122, product of Novozymes A/S), fungal alpha-amylase from  A. oryzae  (Fungamyl\u00ae, product of Novozymes A/S), maltogenic alpha-amylase having the sequence of SEQ ID NO: 1 (Novamyl\u00ae, product of Novozymes A/S), a Novamyl variant having SEQ ID NO: 1 with the substitutions F188L+D261G+T288P, and bacterial alpha-amylase from  B. licheniformis  (Termamyl\u00ae, product of Novozymes A/S). \n       Exo-Amylase Activity \n       [0038]    The five amylases were tested for exo-amylase activity as described above. The results show that Novamyl and the Novamyl variant had exo-amylase activity by this test, and the other three did not. \n       Thermostability \n       [0039]    Each amylase was incubated at 85\u00b0 C. at pH 5.7 (50 mM Na-acetate, 1 mM CaCl 2 ) without substrate, and the amylase activity was measured after 0, 15, 30 and 60 minutes heat treatment. The results are expressed as residual activity in % of the initial activity: \n         [0000]    \n       \n         \n               \n               \n               \n               \n               \n             \n               \n               \n               \n               \n               \n               \n             \n           \n               \n                   \n                   \n               \n               \n                   \n                 0 \n                 15 \n                 30 \n                 60 \n               \n               \n                   \n                   \n               \n             \n             \n               \n                   \n               \n             \n          \n           \n               \n                   \n                 BAN \n                 100 \n                 3 \n                 1 \n                 0 \n               \n               \n                   \n                 Fungamyl \n                 100 \n                 0 \n                 0 \n                 0 \n               \n               \n                   \n                 Novamyl \n                 100 \n                 51 \n                 29 \n                 13 \n               \n               \n                   \n                 Novamyl variant \n                 100 \n                 64 \n                 48 \n                 54 \n               \n               \n                   \n                 Termamyl \n                 100 \n                 100 \n                 71 \n                 85 \n               \n               \n                   \n                   \n               \n             \n          \n         \n       \n     \n         [0040]    The results show that the Novamyl variant and Termamyl were not deactivated by the heat-treatment. BAN and Fungamyl lose all their activity after 15 min while Novamyl loses it gradually with heat-treatment time. \n       Sucrose Tolerance \n       [0041]    The experiment was repeated in 10% sucrose solution. The results are expressed as residual activity in % of the initial activity without sucrose: \n         [0000]    \n       \n         \n               \n               \n               \n               \n               \n             \n               \n               \n               \n               \n               \n               \n             \n           \n               \n                   \n                   \n               \n               \n                   \n                 0 \n                 15 \n                 30 \n                 60 \n               \n               \n                   \n                   \n               \n             \n             \n               \n                   \n               \n             \n          \n           \n               \n                   \n                 BAN \n                 93 \n                 2 \n                 1 \n                 0 \n               \n               \n                   \n                 Fungamyl \n                 31 \n                 0 \n                 0 \n                 0 \n               \n               \n                   \n                 Novamyl \n                 7 \n                 6 \n                 1 \n                 3 \n               \n               \n                   \n                 Novamyl variant \n                 21 \n                 19 \n                 14 \n                 16 \n               \n               \n                   \n                 Termamyl \n                 116 \n                 112 \n                 97 \n                 82 \n               \n               \n                   \n                   \n               \n             \n          \n         \n       \n     \n         [0042]    The results show that BAN and Termamyl were not inhibited by sugar while Fungamyl and the Novamyl variant were somewhat inhibited, and Novamyl was heavily inhibited by sugar. The combination of sugar and heat-treatment shows that the Novamyl variant and Termamyl could be active during baking of cakes. Termamyl and the Novamyl variant fulfill the criterion for thermostability and sugar tolerance used in this invention. \n       Example 4 \n     Preparation of Sponge Cake with Amylase \n       [0043]    Sponge cakes were made with addition of amylase as follows: BAN (0.83. 8.3 or 83 mg/kg flour), Novamyl (1.3 or 13 mg/kg flour) or the Novamyl variant used in Example 1 (1, 10 10 or 100 mg/kg flour). A control cake was made without amylase. \n         [0044]    The cakes were baked according to the High Ratio Sponge Sandwich Cake (HRSSC) method. After baking, the cakes were cooled down for 60-120 minutes, and the cakes were stored at room temperature in sealed plastic bags filled with nitrogen until analysis. The cakes were evaluated on day 1, 3, 7 or 23. \n         [0045]    Texture profile analysis (TPA) was performed as described in Bourne M. C. (2002) 2. ed., Food Texture and Viscosity: Concept and Measurement. Academic Press. The results showed that the increase in hardness was slower with increasing dosage of the Novamyl variant. The addition of BAN or Novamyl had only a slight effect, and only at the highest dosage. \n         [0046]    The cohesiveness of the cakes decreased with storage time. The addition of the Novamyl variant delayed this decrease. The addition of BAN or Novamyl had a slight effect, and only at the highest dosage. \n         [0047]    Water mobility was characterized by low field NMR. The addition of the Novamyl variant and BAN increased the mobility, indicating that the two amylases were able to keep the cakes more moist. Novamyl had virtually no effect. \n         [0048]    A small sensory evaluation of softness and moistness was performed on day 13 for the 3 cakes with the Novamyl variant and the control cake. The cakes were evaluated regarding three parameters; Firmness, Moistness and preferability. The control was the firmest, driest and least preferred. The higher dosage of the Novamyl variant, the less firm (softer), moister and better liked. \n         [0049]    A large panel sensory evaluation was performed on day 13. It was a paired comparison test where a control cake was compare to the cake with the Novamyl variant at the highest dosage. A 30-member panel was asked two questions (1) Which cake is moister and (2) which cake is fresher. All panel members agreed on that the cake with the Novamyl variant was moister and fresher. The preference was significant at a significance level above 99.999%. \n         [0050]    To summarize, the data show that the Novamyl variant had anti-staling properties and was able to improve moistness perception and moistness measured by NMR. The two other amylases had only a slight effect. \n       Example 5 \n     High-Ratio Unit Cakes \n       [0051]    Cakes were made with addition of amylase as follows: BAN (0.83. 8.3 or 83 mg/kg flour) or the Novamyl variant used in Example 1 (1, 10 or 100 mg/kg flour). A control cake was made without amylase. \n         [0052]    Cakes were baked according to the High ratio unit cake (HRUC) method. After baking, the cakes were cooled down for 60-120 minutes, and the cakes were stored at room temperature in sealed plastic bags filled with Nitrogen until analysis. The cakes were evaluated on day 7, 20 and 34 by the same methods as in the previous example. \n         [0053]    The increase in hardness was slower with the Novamyl variant at the highest dosage. The addition of BAN to the cake resulted in a low volume and a doughy cake which gave poor results in hardness measurements. \n         [0054]    The addition of the Novamyl variant delayed the decrease in cohesiveness while BAN did not influence it at all. \n         [0055]    The Novamyl variant and BAN were able to keep the cake more moist than the control. This increase in mobility of the free water could partly be explained by the cakes with BAN and the Novamyl variant being able to retain the moisture content. \n         [0056]    A small sensory evaluation on day 34 showed that the cake with the Novamyl variant at the highest dosage was clearly better than the control cake; it was more moist and it was less crumbly. \n         [0057]    Over-all, there was an anti-staling effect of the Novamyl variant at the high dosage, similar to the effect on sponge cakes in the previous example. The staling of HRUC cakes was slower than Sponge cakes but it was still evident that the Novamyl variant had an anti-staling effect. The anti-staling effect was seen with texture analysis, NMR and sensory evaluation. BAN showed anti-staling effects in HRUC but it was sensitive to over-dosage which resulted in cake collapse and a doughy cake. \n       Example 6 \n     Sponge Cake \n       [0058]    Sponge cakes were made with addition of the amylase of DK PA 2004 00021 at dosages 0.5, 1, 2, 5 and 20 mg/kg flour and a control cake without amylase. \n         [0059]    Texture and NMR was measured on day 1, 7 and 13. The addition of the amylase reduced the increase in firmness, especially at the highest dosage. The amylase also had a beneficial effect on the mobility of water which was correlated with the moistness of the cake. \n         [0060]    A blind sensory ranking evaluation performed on day 14 showed a ranking according to the dosage, the higher dosage the more soft and moist cake. The most preferred cake was the one with the highest dosage. \n       Example 7 \n     Baking Procedure Tegral Allegro Cake \n     Recipe \n       [0061]    The following recipe was used: \n         [0000]    \n       \n         \n               \n               \n             \n               \n               \n               \n             \n           \n               \n                   \n                   \n               \n               \n                   \n                 % \n               \n               \n                   \n                   \n               \n             \n             \n               \n                   \n               \n             \n          \n           \n               \n                   \n                 Tegral Allegro mix* \n                 100 \n               \n               \n                   \n                 Pasteurized whole \n                 50 \n               \n               \n                   \n                 egg \n               \n               \n                   \n                 Butter \n                 50 \n               \n               \n                   \n                 Enzymes \n                 According to trial. 0 or 25 mg/kg \n               \n               \n                   \n                   \n                 flour. \n               \n               \n                   \n                   \n               \n               \n                   \n                 *commercially available from Puratos NV/SA, Groot-Bijgaarden, Belgium \n               \n             \n          \n         \n       \n     \n       Procedure \n       [0062]    The ingredients were scaled into a mixing bowl and mixed using an industrial mixer (e.g. Bj\u00f8rn A R 5 A Varimixer) with a suitable paddle speed. 300 g of the dough was poured into forms. The cakes are baked in a suitable oven (e.g. Sveba Dahlin deck oven) for 45 min. at 180\u00b0 C. The cakes were allowed to cool down at room temperature for 1 hour. \n         [0063]    The volume of the cakes was determined when the cakes had cooled down using the rape seed displacement method. The cakes were packed under nitrogen in sealed plastic bags and stored at room temperature until analysis. \n         [0064]    The cakes were evaluated on day 1, 7 and 14, two cakes were used at each occasions. \n         [0065]    The cohesiveness and hardness of the cakes was evaluated with Texture analyser and the water mobility was characterized by low field NMR. \n         [0066]    The Texture profile analysis (TPA) was performed as described in Bourne M. C. (2002) 2. ed., Food Texture and Viscosity: Concept and Measurement. Academic Press. \n         [0067]    The mobility of free water was determined as described by P. L. Chen, Z. Long, R. Ruan and T. P. Labuza, Nuclear Magnetic Resonance Studies of water Mobility in Bread during Storage. Lebensmittel Wissenschaft and Technologie 30, 178-183 (1997). The mobility of free water has been described in literature to correlate to moistness of bread crumb. \n       Result \n       [0068]    Compared to cakes with no addition of enzymes the volume of the cakes is not affected by the addition of the reference enzyme (SEQ ID NO.: 1) nor by the addition of variants hereof, i.e. the cakes did not collapse upon addition of enzyme. \n         [0069]    The cohesiveness of the cakes decreased with storage time. The addition of variants of SEQ ID NO: 1 delayed this decrease as can be seen in Table 1. \n         [0000]    \n       \n         \n               \n             \n               \n               \n               \n               \n             \n           \n               \n                 TABLE 1 \n               \n             \n             \n               \n                   \n               \n               \n                 Change in Cohesiveness [gs/gs] with storage time of cakes with 25 mg \n               \n               \n                 protein enzyme per kg flour \n               \n             \n          \n           \n               \n                 Enzyme \n                 Day 1 \n                 Day 7 \n                 Day 14 \n               \n               \n                   \n               \n               \n                 No enzyme \n                 0.44 \n                 0.35 \n                 0.32 \n               \n               \n                 Seq ID No: 1 \n                 0.43 \n                 0.38 \n                 0.36 \n               \n               \n                 F188L, D261G, T288P \n                 0.46 \n                 0.42 \n                 0.41 \n               \n               \n                 Y89F, D261G, T288P \n                 0.45 \n                 0.43 \n                 0.39 \n               \n               \n                 N86G, Y89M, F188L, D261G, T288P \n                 0.44 \n                 0.42 \n                 0.38 \n               \n               \n                 T288P \n                 0.44 \n                 0.40 \n                 0.41 \n               \n               \n                 F194S, D261G, T288P \n                 0.47 \n                 0.43 \n                 0.42 \n               \n               \n                 D261G, T288P, D372V \n                 0.46 \n                 0.43 \n                 0.37 \n               \n               \n                 A192Q, D261G, T288P, S446A \n                 0.44 \n                 0.42 \n                 0.39 \n               \n               \n                 A192R, F194L, D261G, T288P, G469R \n                 0.47 \n                 0.44 \n                 0.42 \n               \n               \n                 A192G, D261G, T288P \n                 0.46 \n                 0.42 \n                 0.39 \n               \n               \n                 N86K, F252L, D261G, T288P \n                 0.45 \n                 0.41 \n                 0.39 \n               \n               \n                 F194L, D261G, T288P \n                 0.45 \n                 0.42 \n                 0.42 \n               \n               \n                 F194S, D261G, T288P, P642Q \n                 0.44 \n                 0.40 \n                 0.39 \n               \n               \n                 Y89F, D261G, T288P, I290V, N375S \n                 0.43 \n                 0.42 \n                 0.40 \n               \n               \n                   \n               \n             \n          \n         \n       \n     \n         [0070]    The free water mobility is correlated with the moist perception of the cake crumb, it decreases with time. The addition of the Novamyl variants increased the mobility compared to the control, indicating that the amylases were able to keep the cakes more moist. Results are listed in Table 2. \n         [0000]    \n       \n         \n               \n             \n               \n               \n               \n               \n             \n           \n               \n                 TABLE 2 \n               \n             \n             \n               \n                   \n               \n               \n                 Change in free water mobility [micros] with storage time of cakes with \n               \n               \n                 25 mg protein enzyme per kg flour \n               \n             \n          \n           \n               \n                 Enzyme \n                 Day 1 \n                 Day 7 \n                 Day 14 \n               \n               \n                   \n               \n               \n                 No enzyme \n                 7077 \n                 5111 \n                 4175 \n               \n               \n                 Seq ID No: 1 \n                 6990 \n                 5460 \n                 4583 \n               \n               \n                 F188L, D261G, T288P \n                 7216 \n                 5624 \n                 4656 \n               \n               \n                 Y89F, D261G, T288P \n                 7085 \n                 6044 \n                 5151 \n               \n               \n                 N86G, Y89M, F188L, D261G, T288P \n                 7493 \n                 5349 \n                 5120 \n               \n               \n                 T288P \n                 7458 \n                 5785 \n                 4858 \n               \n               \n                 F194S, D261G, T288P \n                 7746 \n                 6373 \n                 5325 \n               \n               \n                 D261G, T288P, D372V \n                 7417 \n                 5517 \n                 4525 \n               \n               \n                 A192Q, D261G, T288P, S446A \n                 7357 \n                 5714 \n                 5041 \n               \n               \n                 A192R, F194L, D261G, T288P, G469R \n                 7549 \n                 5536 \n                 no data \n               \n               \n                 A192G, D261G, T288P \n                 7546 \n                 5815 \n                 no data \n               \n               \n                 N86K, F252L, D261G, T288P \n                 7349 \n                 5295 \n                 4775 \n               \n               \n                 F194L, D261G, T288P \n                 7773 \n                 6803 \n                 5750 \n               \n               \n                 F194S, D261G, T288P, P642Q \n                 8152 \n                 5969 \n                 4971 \n               \n               \n                 Y89F, D261G, T288P, I290V, N375S \n                 7753 \n                 6175 \n                 4811 \n               \n               \n                   \n               \n             \n          \n         \n       \n     \n         [0071]    The hardness of the cakes increased with storage time. The addition of variants of SEQ ID NO: 1 delayed this increase in hardness as can be seen in Table 3. \n         [0000]    \n       \n         \n               \n             \n               \n               \n               \n               \n             \n               \n               \n               \n               \n             \n           \n               \n                 TABLE 3 \n               \n             \n             \n               \n                   \n               \n               \n                 Change in hardness [g] with storage time of cakes with 25 mg protein \n               \n               \n                 enzyme per kg flour \n               \n             \n          \n           \n               \n                 Enzyme \n                 Day 1 \n                 Day 7 \n                 Day 14 \n               \n               \n                   \n               \n             \n          \n           \n               \n                 No enzyme \n                 647 \n                 1060 \n                 1408 \n               \n               \n                 Seq ID No: 1 \n                 677 \n                 997 \n                 1171 \n               \n               \n                 F188L, D261G, T288P \n                 683 \n                 951 \n                 1167 \n               \n               \n                 Y89F, D261G, T288P \n                 649 \n                 998 \n                 1160 \n               \n               \n                 N86G, Y89M, F188L, D261G, T288P \n                 630 \n                 844 \n                 1194 \n               \n               \n                 T288P \n                 719 \n                 1101 \n                 1098 \n               \n               \n                 F194S, D261G, T288P \n                 672 \n                 943 \n                 1061 \n               \n               \n                 D261G, T288P, D372V \n                 593 \n                 962 \n                 1344 \n               \n               \n                 A192Q, D261G, T288P, S446A \n                 680 \n                 931 \n                 1159 \n               \n               \n                 A192R, F194L, D261G, T288P, G469R \n                 720 \n                 987 \n                 1209 \n               \n               \n                 A192G, D261G, T288P \n                 707 \n                 1024 \n                 1102 \n               \n               \n                 N86K, F252L, D261G, T288P \n                 678 \n                 955 \n                 1248 \n               \n               \n                 F194L, D261G, T288P \n                 648 \n                 895 \n                 1050 \n               \n               \n                 F194S, D261G, T288P, P642Q \n                 674 \n                 1028 \n                 1316 \n               \n               \n                 Y89F, D261G, T288P, I290V, N375S \n                 602 \n                 731 \n                 827", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["A method of sizing liposomes by passing a suspension of liposomes through an aluminum oxide porous film by entering the film via the smaller pores and extruded via the larger pores, under pressure, is disclosed. In a preferred embodiment, the porous film is a branched-pore type anodic aluminum oxide porous film. The process produces a population of liposomes substantially free of liposomes above a predetermined maximum size. Also disclosed is an apparatus for carrying out the invention."], "input": "CROSS-REFERENCES TO RELATED APPLICATIONS \n     This is a continuation of U.S. application Ser. No. 08/441,569, filed May 15, 1995, now abandoned, which is a continuation of U.S. application Ser. No. 08/203,638, filed Mar. 1, 1994, now abandoned, which is a continuation of U.S. application Ser. No. 07/771,267, filed Oct. 4, 1991, now abandoned, which is a continuation-in-part of U.S. application Ser. No. 07/593,200, filed Oct. 5, 1990, now abandoned. \n    \n    \n     FIELD OF THE INVENTION \n     This invention relates to a method of sizing liposomes, and more particularly to a sizing method which includes extruding liposomes through a branched-pore type aluminum oxide porous film. \n     BACKGROUND OF THE INVENTION \n     Liposomes are completely closed lipid bilayer membranes containing an entrapped aqueous volume. Liposomes may be unilamellar vesicles (possessing a single bilayer membrane) or multilamellar vesicles (onion-like structures characterized by multiple membrane bilayers, each separated from the next by an aqueous layer). The bilayer is composed of two lipid monolayers having a hydrophobic \u201ctail\u201d region and a hydrophilic \u201chead\u201d region. The structure of the membrane bilayer is such that the hydrophobic (nonpolar) \u201ctails\u201d of the lipid monolayers orient toward the center of the bilayer while the hydrophilic \u201chead\u201d orient towards the aqueous phase. \n     The original liposome preparation of Bangham, et al. (J. Mol. Biol., 1965, 13:238-252) involves suspending phospholipids in an organic solvent which is then evaporated to dryness leaving a phospholipid film on the reaction vessel. Next, an appropriate amount of aqueous phase is added, the mixture is allowed to \u201cswell\u201d, and the resulting liposomes, which consist of multilamellar vesicles (MLVs), are dispersed by mechanical means. This technique provided the basis for the development of the small sonicated unilamellar vesicles (SUVS) described by Papahadjopoulos et al. ( Biochim. Biophys. Acta.,  1968, 135:624-638), as well as large unilamellar vesicles (LUVs). In addition, U.S. Pat. No. 4,235,871, issued Nov. 25, 1980 to Papahadjopoulos et al., describes a \u201creverse-phase evaporation process\u201d for making oligolamellar lipid vesicles, also known as reverse-phase evaporation vesicles (REVs). \n     Alternative methods have been developed for forming improved classes of multilamellar vesicles which have been shown to have particularly improved properties such as, for example, higher active ingredient trapping efficiencies and loadability, better stability, less leakage, and greater ease of production. One such improved class of liposomes, denominated as stable plurilamellar vesicles (SPLVs), is described in U.S. Pat. No. 4,522,803, issued Jun. 11, 1985 to Lenk et al. Another such improved class, defined as monophasic vesicles (MPVs), is described in U.S. Pat. No. 4,558,578, issued May 13, 1986 to Fountain et al. Both of these classes of liposomes have also been characterized as having substantially equal interlamellar solute distributions. A general review of various methods for producing liposomes, including an extensive bibliography, is set forth in Deamer and Uster, \u201cLiposome Preparation: Methods and Mechanisms\u201d, in the  Liposomes,  edited by M. Ostro, pp. 27-51 (1983), incorporated herein by reference. \n     The administration of drugs encapsulated in or otherwise associated with liposomes has been proposed for use in a variety of drug delivery regimens in combination with or as an alternative to the administration of free drugs. In some applications, liposomes have been found to provide sustained release of drugs for extended periods, which can be of particular importance in the lengthy chemotherapy regimens often required for the treatment of various forms of cancer or AIDS-related illnesses. Another property of liposomes is their ability to be taken up by certain cells, such as phagocytes, such that they can deliver their active ingredient to the interior of the cells. This makes such liposome treatment particularly useful in treating intracellular infections, such as those associated with species of Mycobacteria, Brucella, Listeria, and Salmonella. Thus, drugs encapsulated in liposomes can be delivered for the treatment of such intracellular diseases without administering large amounts of free unencapsulated drug into the bloodstream. In addition, the mere association of certain drugs or other bio-active agents with liposomes has been found to potentiate or improve the activity of such drugs or bio-active agents, or to reduce their toxicity. \n     Liposomes behave like particles, and are commonly described in terms of average particle size and particle-size distributions. For certain uses of liposomes, particularly in the parenteral administration of drugs, it is important to size the liposomes to a desired average particle size, and to maintain a controlled particle-size distribution, particularly by sizing the liposomes so that substantially all of the liposomes are of a size below a predetermined maximum diameter. For liposomes intended for parenteral administration, one desirable size range is between about 100 and 1000 nm, preferably between about 100 and 500 nm. (As used herein, nm represents nanometer (10 \u22129  m) and um represents micrometer or micron (10 \u22126  m).) The maximum desired size range is often limited by the desire to sterilize the liposomes by filtering through conventional sterilization filters, which commonly have a particle-size discrimination of about 200 nm. However, overriding biological efficacy and/or safety factors may dictate the need for a particular particle size, either larger or smaller. Control of the size range of the liposomes may also improve the effectiveness of the liposomes in vivo, as well as the stability and leakage resistance of the liposomes. \n     The various methods for producing liposomes generally produce a suspension of liposomes of widely varying sizes, many of which exceed 1000 nm in average particle size. A number of methods have been proposed to reduce the size and size distribution of liposomes in such suspensions. In a simple homogenization method, a suspension of liposomes is repeatedly pumped under high pressure through a small orifice or reaction chamber until a desired average size of liposome particles is achieved. A limitation of this method is that the liposome size distribution is typically quite broad and variable, depending on the number of homogenization cycles, pressures, and internal temperature. \n     Small unilamellar vesicles (SUVs), generally characterized as having diameters below 100 nm, are composed of highly strained, curved bilayers. The SUVs are typically produced by disrupting larger liposomes via ultrasonication. It has been found that a narrow size distribution of such liposomes can only be achieved when the liposomes have been reduced to their smallest sizes, less than about 50 nm. Furthermore, this process may not be amenable to large-scale production, because it is generally conducted as a batch process with long-term sonication of relatively small volumes. In addition, heat build-up during sonication can lead to peroxidative damage to lipids, and sonication probes may shed titanium particles which are potentially quite toxic in vivo. \n     A method of sizing liposomes by filtration through a 200-nm Unipore\u2122 polycarbonate filter is discussed in Szoka,  Proc. Natl. Acad. Sci. U.S.A.,  75:4194-8 (1978). A size-processing method based on liposome extrusion through a series of uniform straight-pore type polycarbonate membranes from about 1000 nm down to about 100 nm is described in Hunt et al., U.S. Pat. No. 4,529,561, issued Jul. 16, 1985. However, this method can be relatively slow, often requiring many passes through various size filters to obtain the desired particle-size distribution. \n     Vesicles may also be size-reduced using an extrusion process described in Cullis et al., U.S. Pat. No. 5,008,050, issued Apr. 16, 1991, incorporated herein by reference. Vesicles made by this technique are extruded under pressure through a filter with a pore size of 100 nm or less. This procedure avoids the problems of the above homogenization and sonication methods, and does not require multiple passes through decreasing size filters, as described in the above-cited U.S. Pat. No. 4,529,561. Such a process can provide size distributions of liposomes that are quite narrow, particularly by cycling the material through the selected size filter several times. In addition, it is believed that such extrusions may convert multilamellar vesicles into oligolamellar or even unilamellar form, which may be desired for certain applications. However, as demonstrated by the Examples set forth below in the present specification, when such extrusions are made through 100-nm polycarbonate filters, such as the Nuclepore\u2122 filters used in the examples of this reference, even at relatively high pressures flow rates may be relatively low. \n     U.S. Pat. No. 4,737,323, issued Apr. 12, 1988, describes a method for sizing liposomes by extrusion through an asymmetric ceramic filter. Such filters are designed for operation at relatively high pressure, and can be backflushed to prevent clogging. U.S. Pat. No. 4,927,637, issued May 23, 1990 describes a method of sizing liposomes by passing them through a polymer filter having a web-like \u201ctortuous-path\u201d construction. \n     An alternative type of filter medium is described in Furneaux et al., U.S. Pat. No. 4,687,551, issued Aug. 18, 1987. This patent discloses a new type of filter sheet comprising an anodic aluminum oxide film having branched pores extending from one surface of the film to the other. The film is unique in that it includes a system of larger pores extending in from one face and a system of smaller pores extending in from the other face. The system of larger pores interconnects with the system of smaller pores such that the inner ends of one or more smaller pores are joined to the inner end of a larger pore and there are substantially no blind larger pores. This patent is incorporated by reference into the present specification for the purpose of disclosing such branched-pore type aluminum oxide porous films and the method for forming them. \n     In a particular embodiment, the branched-pore anodic aluminum oxide film of the Furneaux et al. patent is described as: \n     An anodic aluminum oxide film having pores extending from one face of the film to the other, \n     including a system of larger pores extending in from one face a distance into the film, the larger pores having a diameter d near their inner ends, and a system of smaller pores extending in from the other face a distance s into the film, the smaller pores having a substantially uniform minimum diameter p, \n     the system of larger pores interconnecting with the system of smaller pores, such that the inner ends of one or more smaller pores are joined to the inner end of a larger pore and there are substantially no blind larger pores, wherein \n     d is 10 nm to 2 um \n     p is at least 2 nm but less than 0.5 d, and \n     s is 10 nm to 1 um. \n     The size rating of such branched-pore type films is equal to p, the substantially uniform minimum diameter of the smaller pores. \n     Filtration membranes made in accordance with the disclosure of the Furneaux et al. patent are commercially available and sold by the Anotec Separations, New York, N.Y., under the name Anopore\u2122. Additional information regarding such branched-pore type membranes is provided in Furneaux et al., \u201cThe Formation of Controlled-Porosity Membranes from Anodicaily Oxidized Aluminum\u201d,  Nature  337:147-9 (1989). \n     One use of such branched-pore Anopore\u2122 filters is described in Jones et al., \u201cComparison of a New Inorganic Membrane Filter (Anopore) with a Track-Etched Polycarbonate Membrane Filter (Nuclepore) for Direct Counting of Bacteria\u201d,  Applied and Environmental Microbiology  55(2):529-30 (1989). This article compares the bacteria filtering ability of a 200-nm-pore-size Anopore\u2122 filter against a 200-nm-pore-size Nuclepore\u2122 filter. \n     SUMMARY OF THE INVENTION \n     In accordance with the method of the present invention, a population of liposomes substantially free of liposomes above a predetermined maximum size is produced by (1) providing a suspension of liposomes, a portion of which are of sizes larger than the predetermined maximum size; and (2) passing the suspension under pressure one or more times through an aluminum oxide porous film. \n     Films with a pore size of 1000 nm or less may be used to obtain liposomes with an average particle size of in the range of about 100 to 1000 nm. In a particular embodiment of the present invention, a film with a pore-size rating of 200 nm or less is used to obtain a population of liposomes with a predetermined maximum diameter of less than about 500 nm. In another embodiment, a film with a Pore size of about 100 nm or less is used, and the suspension of liposomes is passed through the filter one or more times until the average liposome particle size is about 100 to 200 nm. \n     In a further embodiment of the present invention, the suspension of liposomes is passed repeatedly through the porous film until a desired particle size distribution is obtained. In a particular embodiment, the liposomes are passed through the porous film two to ten times. In an additional embodiment, the liposomes are presized by being passed one or more times through a 2-10 micrometer filter. \n     A preferred film for use in the present invention is a branched-pore type anodic aluminum oxide porous film. As discussed above, such a branched-pore anodic aluminum oxide porous film is an aluminum oxide sheet having two substantially parallel major faces with pores extending from one face of the sheet to the other, including a system of larger pores extending from one face into the sheet and a system of smaller pores extending in from the other face, the system of larger pores interconnecting with the system of smaller pores such that the inner ends of one or more smaller pores are joined to the inner end of a larger pore and there are substantially no blind larger pores. The size rating of such branched-pore type films is equal to the minimum diameter of the smaller pores, which are preferably substantially uniform. \n     In a further embodiment of the present invention, apparatus is provided for carrying out the filtration method. The apparatus comprises one or more filter assemblies for holding the aluminum oxide porous films in operational configuration, means for supplying the suspension of liposomes to the filter assemblies, and means to receive the filtrate from the assemblies. In a particular embodiment, two or more assemblies are used in parallel configuration to filter the liposome suspension passing from the supply means to the receiving means. Optionally, means can also be provided for recirculating at least a portion of the filtrate from the receiving means back to the supply means, thus providing for multiple passes of the liposomes through the filters. In addition, a sterilization filter can be provided downstream of the receiving means, as may be appropriate to prepare the filtrate for pharmaceutical use. \n     The extrusion is rapid and inexpensive, and does not require the use of solvents or other chemicals that must be removed. \n    \n    \n     BRIEF DESCRIPTION OF THE DRAWINGS \n     FIG. 1 is a simplified top view, not to scale, of a filter assembly made in accordance with the present invention. \n     FIG. 2 is a simplified cross-sectional side view, not to scale, through line  2 \u2014 2  of FIG. 1, of the filter assembly shown in FIG.  1 . \n     FIG. 3 is a schematic representation of an extrusion system made in accordance with the present invention. \n    \n    \n     DETAILED DESCRIPTION OF THE INVENTION \n     As discussed in the Furneaux et al. references cited above, aluminum can be anodized in acid to produce a uniform array of cells or openings having cylindrical pores which preferably branch from larger pore-size openings in one face of the film to smaller pore-size openings in the other face of the film. Such filters are available in a variety of pore sizes, and ones having a pore size of the smaller pores of less than about 1000 nm are preferred for use in the present invention, although smaller or larger pore-sizes can be used depending on the final application of the liposomes. (Hereinafter, unless otherwise noted, \u201cpore size\u201d for such filters shall refer to the minimum pore size of the smaller pores.) At present, of the Anopore\u2122 anodized aluminum porous filters commercially available from Anotec Separations, those of pore size under 200 nm are of the branched-pore structure, and those of pore size of 200 nm or larger are of uniform pore size from one surface to the other. When the desired average particle size of the liposomes is less than about 200 nm, then the preferred pore size of the filter is less than about 100 nm. These filters are also of the preferred branched-pore type structure. \n     These aluminum oxide filters are hydrophilic; they do not swell in aqueous solvents; they have good organic solvent resistance; and they have pores of uniform size which promote high flow-through characteristics. Because of the properties of such films, it was found that liposomes could be extruded through them at relatively high flow rates under relatively low pressure (see Example 3, below). Thus, aluminum oxide filters are shown to be superior for extruding liposomes over the previously known polymeric filters. \n     In the present invention, the branched-pore filters are preferably used so that the liposomes enter the face with the smaller size pores and exit though the face with the larger size pores. However, as shown in the examples below, good extrusion can also be obtained with a filter mounted in the inverted position, so that the liposomes enter the large pore-size face. \n     In accordance with the process of present invention, a population of liposomes substantially free of liposomes above a predetermined maximum size is produced from a suspension of liposomes, a portion of which are of sizes larger than the predetermined maximum size. The process includes passing the suspension of liposomes under pressure one or more times through an aluminum oxide porous film, such as one of the type described above. \n     To determine whether a population of liposomes is \u201csubstantially free of liposomes above a predetermined maximum size\u201d, the liposomes can be tested using a standard sizer. One such standard sizer is a Malvern Sizer, available from Malvern Instruments, Malvern, England, which is described and used in some of the examples below. Another sizer which can used to determine particle size distributions is a Nicomp\u2122 laser particle sizer, available from Hiac/Royco Instruments, Menlo Park, Calif., which is also described and used in some of the examples below. In the particle size distributions reported in the examples below, a test result indicating that 0.0 percent of the liposomes present in the population are above a given size indicates that the population is \u201csubstantially free\u201d of such large-size liposomes. \n     Although not required, the particle size, and particularly the particle-size distribution, of liposomes may be made smaller and more uniform by extruding though a larger filter as a first step. For example, extruding the liposomes through a suitable filter of 2-10 micrometer size, such as one made from polytetrafluoroethylene (PTFE), as is well known in the art, will reduce the particle size and particle-size distribution prior to extruding through the aluminum oxide filter, and may thereby reduce the time for extrusion. \n     The pressure during the extrusion will be varied depending upon the liposomes employed, their mean particle diameter and particle-size distribution, and the rate of flow desired. Extrusion pressures may vary from about 200 to about 1000 psi (1.4-6.9 MPa), but pressures of less than about 600 psi (4.2 MPa) are preferred. \n     In general, fewer extrusion passes are required when using the branched-pore type aluminum oxide filters of the present invention, as opposed to the previously known polycarbonate filters, for similar results in terms of particle size, particle-size distribution and flow rates. However, repeated extrusion passes through the aluminum oxide filters may be used to obtain a narrower particle-size distribution, and particularly to reduce all liposomes to below a predetermined maximum size. For example, 2-10 extrusions of the liposomes through the filters are preferred to decrease the particle-size distribution, thereby producing relatively uniform liposomes of high capacity in a rapid, efficient and inexpensive manner. Multiple extrusions may also convert multilamellar vesicles to more desired oligolamellar or unilamellar forms. \n     Subsequent to the extrusion process of the invention, any free unencapsulated therapeutic agent or other solution can be readily removed, as by dialysis or diafiltration, leaving stable drug encapsulating liposomes of relatively uniform size. The resultant liposomes may be readily measured into uniform dosages for administration parenterally or orally. \n     The invention will be further illustrated by the following examples, but the invention is not meant to be limited to the details described therein. \n     EXAMPLE 1 \n     Preparation of Liposomes \n     Three batches of liposomes (hereinafter designated A, B and C) were prepared as follows: \n     71.3 mg/ml egg phosphatidylcholine (obtained from Princeton Lipids, Princeton, N.J.) and 28.7 mg/ml cholesterol (J. T. Baker, Phillipsburg, N.J.) were dissolved in 0.15 to 0.5 ml of methylene chloride and added to a 300-mM citrate buffer solution (pH 4.0) to make up a 1-ml volume. The methylene chloride was removed by heating the mixture to about 40\u00b0 C. To aid in the removal of the solvent, nitrogen was sparged through Batches A and C, while Batch B was heated under partial vacuum. \n     The resultant liposomes were vesicles of various sizes and various size distributions. The initial size distributions of these liposomes prior to size reduction were measured on a Malvern Sizer 3600 E Type with a 63-mm lens, available from Malvern Instruments, Malvern, England. The results are presented in Table I, in which the mean diameters and size distribution ranges are expressed in micrometers (um). Before extrusion, Batch B was presized through a 5-um pore-size Mitex\u2122 PTFE filter (Millipore Corp., Bedford, Mass.), and the mean diameter and distribution range for the Batch B liposomes after presizing is included in the table. Batches A and C were not put through presizing. The results show a considerable batch-to-batch variation in the size distribution of the unsized liposomes. \n     \n       \n         \n               \n             \n               \n               \n               \n               \n             \n               \n               \n               \n               \n             \n           \n               \n                 TABLE I \n               \n             \n             \n               \n                   \n               \n               \n                 Liposome Sizes Prior to Extrusion \n               \n             \n          \n           \n               \n                   \n                 Batch \n                 Mean Diameter (um) \n                 Distribution Range (um) \n               \n               \n                   \n                   \n               \n             \n          \n           \n               \n                   \n                 A \n                 23.2 \n                 1.5-118 \n               \n               \n                   \n                 B \n                 14.9 \n                 1.5-118 \n               \n               \n                   \n                 B* \n                 2.5 \n                 &lt;1.2-5\u2003\u2009\u2009 \n               \n               \n                   \n                 C \n                 3.3 \n                 &lt;1.2-14\u2002\u2009\u2009 \n               \n               \n                   \n                   \n               \n               \n                   \n                 *After 5 micrometer presizing  \n               \n             \n          \n         \n       \n     \n     EXAMPLE 2 \n     Extrusion of Liposomes \n     In accordance with the present invention, the liposomes of Example 1 were extruded five times under pressure through an Anopore\u2122 90-mm diameter, 100-nm pore size (small pores) branched-pore aluminum oxide filter of the type described above. The placement of the filter for Batches A and B was with the input through the small-pore surface. Good results were also obtained for Batch C, which was extruded with the filter inverted so that the input was through the large-pore surface. The mean diameter of the liposomes and the particle-size distributions of the liposomes were measured after the indicated passes through the filter. The size distributions were measured on a Nicomp\u2122 Model 370 laser particle sizer, available from Hiac/Royco Instruments, Menlo Park, Calif. The results measured after each extrusion pass are summarized in Table II: \n     \n       \n         \n               \n             \n               \n               \n               \n               \n               \n               \n             \n           \n               \n                 TABLE II \n               \n             \n             \n               \n                   \n               \n               \n                 Mean Diameter and Particle Size Distribution \n               \n               \n                 After Each Extrusion Pass \n               \n             \n          \n           \n               \n                   \n                 Extrusion \n                 Mean \n                   \n                 0.1- \n                   \n               \n               \n                 Pressure \n                 Rate \n                 Diameter \n                 &lt;0.1 um \n                 0.45 um \n                 &gt;0.45 um \n               \n               \n                 PSI (MPa) \n                 Liters/min \n                 (um) \n                 percent \n                 percent \n                 percent \n               \n               \n                   \n               \n               \n                 Batch A: \n               \n               \n                 325 (2.2) \n                 NT \n                 NT \n                 NT \n                 NT \n                 NT \n               \n               \n                   \n                 0.2 \n                 0.188 \n                 2.6 \n                 94.4 \n                 3.0 \n               \n               \n                   \n                 0.2 \n                 0.168 \n                 6.7 \n                 92.6 \n                 0.8 \n               \n               \n                   \n                 0.2 \n                 0.132 \n                 7.6 \n                 92.3 \n                 0.0 \n               \n               \n                   \n                 0.2 \n                 0.123 \n                 3.6 \n                 96.4 \n                 0.0 \n               \n               \n                 Batch B: \n               \n               \n                 500 (3.4) \n                 0.02 \n                 0.180 \n                 19.1 \n                 78.6 \n                 2.2 \n               \n               \n                 changed filter \n               \n               \n                 300 (2.1) \n                 1.1 \n                 0.139 \n                 6.3 \n                 73.7 \n                 0.1 \n               \n               \n                   \n                 1.2 \n                 0.133 \n                 20.2 \n                 79.8 \n                 0.0 \n               \n               \n                   \n                 1.5 \n                 0.126 \n                 35.1 \n                 64.9 \n                 0.0 \n               \n               \n                   \n                 1.5 \n                 0.116 \n                 36.1 \n                 63.9 \n                 0.0 \n               \n               \n                 Batch C: \n               \n               \n                 (inverted filter) \n               \n               \n                 300 (2.1) \n                 0.7 \n                 0.665 \n                 1.0 \n                 48.3 \n                 50.6 \n               \n               \n                   \n                 0.7 \n                 0.162 \n                 23.2 \n                 76.2 \n                 0.6 \n               \n               \n                   \n                 0.7 \n                 0.143 \n                 26.5 \n                 73.3 \n                 0.1 \n               \n               \n                   \n                 0.3 \n                 0.149 \n                 22.5 \n                 77.5 \n                 0.0 \n               \n               \n                 325 (2.2) \n                 0.5 \n                 0.144 \n                 23.6 \n                 76.3 \n                 0.0 \n               \n               \n                   \n               \n               \n                 NT\u2014not tested  \n               \n             \n          \n         \n       \n     \n     COMPARATIVE EXAMPLE \n     For comparison, a sample of the liposomes prepared in Batch C of Example I was extruded through a total of eight passes, first five times through a 90-mm diameter, 200-nm pore size Nuclepore\u2122 polycarbonate filters, two times through a 100-nm Nuclepore\u2122 filter, and once though a 220-nm sterilization filter. (Nuclepore\u2122 filters are commercially available from Nuclepore, Inc., Pleasanton, Calif.) A second sample was extruded in four passes through a 90-mm diameter, 100-nm pore size Anopore\u2122 filter, in accordance with the present invention. As with the first sample, this sample was then passed through a 220-nm sterilization filter. Size data was measured after the pass numbers indicated in the first column. All of the extrusions were conducted at the same pressure of 400 psi (2.8 MPa). The results are presented in Table III: \n     \n       \n         \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n           \n               \n                 TABLE III \n               \n             \n             \n               \n                   \n               \n               \n                 Mean Diameter and Particle Size Distribution after Extrusion \n               \n             \n          \n           \n               \n                   \n                   \n                 Extrusion \n                 Mean \n                   \n                 0.1- \n                 &gt;0.45 \n               \n               \n                 Pass \n                 Pressure \n                 Rate \n                 Diameter \n                 &lt;0.1 um \n                 0.45 um \n                 um \n               \n               \n                 Number \n                 PSI (MPa) \n                 Liters/min \n                 (um) \n                 Percent \n                 Percent \n                 Percent \n               \n               \n                   \n               \n             \n          \n           \n               \n                 Sample 1: \n               \n               \n                 200-nm Nuclepore \n               \n             \n          \n           \n               \n                 5 \n                 400 (2.8) \n                 0.7 \n                 0.195 \n                 8.5 \n                 90.1 \n                 1.4 \n               \n             \n          \n           \n               \n                 100-nm Nuclepore \n               \n             \n          \n           \n               \n                 6 \n                 400 \n                 0.3 \n                 0.168 \n                 13.5 \n                 86.3 \n                 0.3 \n               \n               \n                 7 \n                 400 \n                 0.2 \n                 NT \n                 NT \n                 NT \n                 NT \n               \n             \n          \n           \n               \n                 220-nm sterile filter \n               \n             \n          \n           \n               \n                 8 \n                   \n                 NT \n                 0.152 \n                 4.0 \n                 96.1 \n                 0.0 \n               \n             \n          \n           \n               \n                 Sample 2: \n               \n               \n                 100-nm Anopore \n               \n             \n          \n           \n               \n                 2 \n                 400 (2.8) \n                 0.7 \n                 0.174 \n                 22.0 \n                 76.9 \n                 1.1 \n               \n               \n                 4 \n                 400 \n                 0.8 \n                 0.146 \n                 17.5 \n                 82.5 \n                 0.0 \n               \n             \n          \n           \n               \n                 220-nm sterile filter \n               \n             \n          \n           \n               \n                 5 \n                   \n                 NT \n                 0.150 \n                 12.0 \n                 88.0 \n                 0.0 \n               \n               \n                   \n               \n               \n                 NT\u2014not tested  \n               \n             \n          \n         \n       \n     \n     The branched-pore type aluminum oxide filters of the present invention required fewer passes with a higher flow rate than the polycarbonate filters to obtain a similar particle-size distribution. \n     EXAMPLE 3 \n     An additional test was conducted to compare the size-reduction capabilities of a branched-pore type anodized aluminum oxide film with an equivalent pore-sized polycarbonate filter. The tests were performed using egg phosphatidylcholine and cholesterol liposomes, made in accordance with Example 1, with the liposomes in aqueous suspension at 100 mg/ml. For this example, the cholesterol was obtained from Croda Chemicals, New York, N.Y. The initial size distribution, as measured on the Malvern Sizer, showed a median diameter of 10.9 um, and a range of diameters of 2.4 to 118 um. To facilitate submicron size reduction, the batch was processed twice through a 5-um Mitex\u2122 PTFE filter at a pressure of 100 psi (0.7 MPa). After this step, the median diameter of the liposomes was measured as 3.5 um, and the range of diameters was 1.9 to 11 um. \n     The batch was divided into two portions. Portion number one was extruded through a 0.1 micrometer Anopore\u2122 filter, and portion two was extruded through a 0.1 micrometer Nuclepore\u2122 polycarbonate filter. The starting extrusion pressure for both portions was 300 psi (2.1 MPa). The extrusion flow rate, particle size, and particle size distribution were measured for each pass through the filters. A total of five passes were performed on each portion. The results are presented in Table IV: \n     \n       \n         \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n               \n             \n               \n               \n               \n               \n               \n               \n               \n             \n           \n               \n                 TABLE IV \n               \n             \n             \n               \n                   \n               \n               \n                 Mean Diameter and Particle Size Distribution after Extrusion \n               \n             \n          \n           \n               \n                   \n                   \n                 Extrusion \n                 Mean \n                   \n                 0.1- \n                 &gt;0.45 \n               \n               \n                 Pass \n                 Pressure \n                 Rate \n                 Diameter \n                 &lt;0.1 um \n                 0.45 um \n                 um \n               \n               \n                 Number \n                 PSI (MPa) \n                 Liters/min \n                 (um) \n                 Percent \n                 Percent \n                 Percent \n               \n               \n                   \n               \n             \n          \n           \n               \n                 Portion 1 (Anopore 100-nm filter): \n               \n             \n          \n           \n               \n                 1 \n                 300 (2.1) \n                 0.6 \n                 0.565 \n                 0.0 \n                 38.6 \n                 61.4 \n               \n               \n                 2 \n                 300 \n                 0.7 \n                 0.212 \n                 10.5 \n                 85.8 \n                 3.7 \n               \n               \n                 3 \n                 300 \n                 0.8 \n                 0.186 \n                 10.5 \n                 88.7 \n                 0.8 \n               \n               \n                 4 \n                 300 \n                 0.8 \n                 0.172 \n                 3.6 \n                 96.4 \n                 0.0 \n               \n               \n                 5 \n                 300 \n                 0.8 \n                 0.165 \n                 10.7 \n                 89.3 \n                 0.0 \n               \n             \n          \n           \n               \n                 Portion 2 (Nuclenore 100-nm filter): \n               \n             \n          \n           \n               \n                 1 \n                 300 (2.1)- \n                 0.02 \n                 1.390 \n                 0.0 \n                 17.6 \n                 82.4 \n               \n               \n                   \n                 500 (3.4)* \n               \n               \n                 2 \n                 700 (4.8) \n                 0.2 \n                 0.215 \n                 11.2 \n                 84.9 \n                 4.0 \n               \n               \n                 3 \n                 700 \n                 0.2 \n                 0.178 \n                 6.5 \n                 93.2 \n                 0.3 \n               \n               \n                 4 \n                 700 \n                 0.2 \n                 0.167 \n                 7.4 \n                 92.6 \n                 0.0 \n               \n               \n                 5 \n                 700 \n                 0.3 \n                 0.158 \n                 19.1 \n                 80.9 \n                 0.0 \n               \n               \n                   \n               \n               \n                 *\u2014Pressure increased from 300 to 500 psi after 65% filtered.  \n               \n             \n          \n         \n       \n     \n     These data demonstrate that both filters are capable of producing similar size distributions with the same number of passes. However, the aluminum oxide filter used for the first portion required less pressure and operated at a much higher flow rate than the polycarbonate filter used for the second portion. All of the passes through the aluminum oxide filter were conducted at 300 psi (2.1 MPa), with flow rates of 0.6-0.8 liters/min. When the extrusion was repeated using the polycarbonate filter, the initial pressure had to be increased from 300 psi (2.1 MPa) to 500 psi (3.4 MPa) just to complete the first pass through the filter at a very low flow rate of 0.02 liter/min. For passes 2 through 5, a higher pressure of 700 psi (4.8 MPa) was needed to maintain a flow rate of 0.2-0.3 liter/min. \n     EXAMPLE 4 \n     A further test was conducted to study the differences in the extrusion properties of liposomes with respect to the orientation of the 100 nm Anopore\u2122 branched-pore filter used to size reduce the liposomes. As discussed above, the Anopore 0.1 um branched-pore filter has a small-pore side, having 100 nm pores, and a large-pore side, having 200 nm pores. In this test, a comparison was made to determine the effects of passing aliquots of the same liposome material through the 100 nm Anopore filters with the small-pore side upstream or with the large-pore side upstream. \n     The test was performed using egg phosphatidylcholine and cholesterol liposomes, made in accordance with Example 1, with the liposomes in aqueous suspension at 100 mg/ml. The material was prepared in a single-five liter lot, mixed well, and divided into four 750 mL samples (A-D). Samples A and B were extruded using the 100-nm upstream orientation, and samples C and D used the 200-nm upstream orientation. Extrusion of the liposomes was carried out by passing them twice though the branched-pore filters, under 400 psig (2.8 MPa) pressure. \n     The particle size distributions of the filtered materials from each of the test samples were measured using a Nicomp\u2122 sizer, as described in Example 2, and found to be generally equivalent. However, the time required to size reduce the liposomes was significantly less for samples A and B, with the 100-nm filter side upstream, as opposed to samples C and D, with the 200-nm filter side upstream. Table V presents the mean particle size diameter in nanometers (nm) and the filtration time in minutes (min): \n     \n       \n         \n               \n             \n               \n               \n               \n             \n               \n               \n               \n               \n               \n               \n             \n           \n               \n                 TABLE V \n               \n             \n             \n               \n                   \n               \n               \n                 Mean Diameters and Extrusion Rates by Filter Orientation \n               \n             \n          \n           \n               \n                   \n                 Mean Diameter (nm) \n                 Filtration Time (min) \n               \n             \n          \n           \n               \n                 Sample \n                 Start \n                 Pass 1 \n                 Pass 2 \n                 Pass 1 \n                 Pass 2 \n               \n               \n                   \n               \n               \n                 A \n                 199 \n                 152 \n                 138 \n                 0.95 \n                 0.85 \n               \n               \n                 B \n                 199 \n                 151 \n                 131 \n                 0.52 \n                 0.53 \n               \n               \n                 C \n                 199 \n                 157 \n                 139 \n                 4.93 \n                 1.03 \n               \n               \n                 D \n                 199 \n                 169 \n                 153 \n                 3.08 \n                 0.97 \n               \n               \n                   \n               \n             \n          \n         \n       \n     \n     The extruded material was then sterile filtered through a 220-nm sterilization filter, of the same type used in the Comparative Example. The sterilization filter used in this test, and in the above Comparative Example, was a commercially available Millipak\u2122 200 filter supplied by Millipore Corp., Bedford, Mass, and described as having a Durapore\u2122 polyvinylidene difluoride (PVDF) tortuous path membrane. Sterile filtration was considered complete when all of the material had passed through the sterilization filter, or when the steady stream of material had broken into a slow drip. The mean particle diameter (nm), the time required to pass through the filter (min), and the percent volume of material which passed through the sterilization filter were measured for each sample, and the results are presented in Table VI: \n     \n       \n         \n               \n             \n               \n               \n               \n               \n               \n             \n               \n               \n               \n               \n               \n             \n           \n               \n                 TABLE VI \n               \n             \n             \n               \n                   \n               \n               \n                 Effect of Extrusion Filter Orientation on \n               \n               \n                 Subsequent Sterile Filtration \n               \n             \n          \n           \n               \n                   \n                   \n                 Mean \n                 Filtration \n                 Percent Through \n               \n               \n                   \n                 Sample \n                 Diameter (nm) \n                 Time (min) \n                 Filter \n               \n               \n                   \n                   \n               \n             \n          \n           \n               \n                   \n                 A \n                 133 \n                 2.67 \n                 96% \n               \n               \n                   \n                 B \n                 126 \n                 0.68 \n                 100% \n               \n               \n                   \n                 C \n                 131 \n                 1.95 \n                 47% \n               \n               \n                   \n                 D \n                 151 \n                 1.27 \n                 44% \n               \n               \n                   \n                   \n               \n             \n          \n         \n       \n     \n     These data demonstrate that the sterile filtration was very efficient for samples A and B, in which almost all of the material successfully passed through the sterilization filter. In contrast, only about half of the volume of samples C and D was able to pass through the sterilization filter before the flow stopped. \n     EXAMPLE 5 \n     FIG. 1 is a simplified top view, not to scale, of a filter assembly ( 10 ) made in accordance with a particular embodiment of the present invention, designed for use with a 90-mm diameter Anopore\u2122 filer. It should also be recognized that this filter assembly could also be used to house other types of filters as well, such as, for example, the Nuclepore\u2122 filters used in the comparative tests in Example III above. FIG. 2 is a simplified cross-sectional side view, not to scale, of figure assembly ( 10 ) cut along line  2 \u2014 2  of FIG.  1 . Filter assembly ( 10 ) comprises a filter housing top half ( 11 ) and a filter housing bottom half ( 12 ), held together by a plurality of fastening screws ( 13 ). Referring to FIG. 2, filter unit ( 14 ) represents a 90-mm Anopore filter mounted on a drain disk (Nuclepore Catalog #231700) cut to 90 mm, which is in turn mounted on a 90-mm Teflon R  coated mesh filter support (Millipore Catalog #YY30 090 54). Filter unit ( 14 ) is in turn mounted on a stainless steel filter support plate ( 15 ), which is provided with fluid passage means, such as transverse channels ( 16 ). Support plate ( 15 ) sits into a seat portion ( 17 ) of filter housing bottom half ( 12 ), with the seat portion ( 17 ) provided with radial grooves (not shown) to channel the liquid which passes through the filter into liquid outlet ( 18 ). Filter housing top half ( 11 ) includes a ring portion ( 19 ) which holds filter unit ( 14 ) in place when top half ( 11 ) is tightened down onto bottom half ( 12 ) by screws ( 13 ). \n     In operation, the liquid to be filtered enters filter assembly ( 10 ) through liquid inlet ( 20 ), flows through filter unit ( 14 ) and filter support plate ( 15 ), and then is channeled out through filter outlet ( 18 ). Preferably, housing top half ( 11 ) is provided with a relief outlet ( 21 ), by which a relief valve (not shown) can be connected to the housing. \n     Although filter assembly ( 10 ) has been described in terms of a \u201ctop half\u201d and a \u201cbottom half\u201d, these references are for purposes of describing the structure, and do not reflect the orientation of the housing in operation. Because the liquid being filtered is sent to the assembly at such relatively high pressures, it is believed that the assembly can be used in any orientation. \n     FIG. 3 is a schematic representation of an extrusion system made in accordance with the present invention. The liposome composition to be filtered is contained in a high pressure supply vessel ( 31 ), and the filtrate is collected in a similar receiving vessel ( 32 ). Both of these vessels are shown as being equipped with stirrers to maintain the liposome mixtures, and heat jacketed for temperature control. The liquid exits supply vessel ( 31 ) through a bottom outlet, and is carried through a one or more filter assemblies ( 33 ), of the type described above, containing 90-mm Anopore\u2122 filters. The filter assemblies ( 33 ) are connected in parallel, with the number of such assemblies used determined by the desired total flow rate from supply vessel ( 31 ) to receiving vessel ( 32 ). From receiving vessel ( 32 ), the filtrate is forced through a sterilization filter ( 35 ), such as a Millipak\u2122 200 filter as described in Example 4 above, and is then collected in a stirred holding vessel ( 36 ). In addition, a recycle line ( 34 ) may be provided to allow a portion of the output of receiving vessel ( 32 ) to be recycled to supply vessel ( 31 ). \n     The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["Disclosed are articles of footwear and soles therefor, in particular sports shoe soles that include openings for ventilation and vapor exchange. The soles include an insole layer with a plurality of first openings, a support layer with a plurality of second openings that partially overlap the plurality of first openings, and an outsole layer with at least one third opening that at least partially overlaps the plurality of second openings to provide fluidic communications through the sole from an interior of the shoe to an exterior of the shoe. A substantial portion of the plurality of first openings in the insole are interconnected to provide a path for diffusion. The shoes and soles can include a cushioning layer, a tread layer, a breathable membrane, and additional support elements. In addition, the shoes can be used with climate control socks to further enhance the climate control properties of the shoes."], "input": "CROSS-REFERENCE TO RELATED APPLICATION  \n         [0001]    This application incorporates by reference, and claims priority to and the benefit of, German patent application serial number 10036100.5, which was filed on Jul. 25, 2000.  \n         TECHNICAL FIELD  \n         [0002]    The invention generally relates to articles of footwear and soles therefor. In particular, the invention relates to a sole for athletic or sports footwear that includes openings for ventilation and vapor exchange.  \n         BACKGROUND INFORMATION  \n         [0003]    The technical development of shoes, in particular sport shoes, has advanced in recent years. Presently, shoe constructions can be adapted to accommodate the mechanical stresses arising on a wearer&#39;s foot during different kinds of sporting activities and provide a high degree of functionality and wearing comfort. In spite of these developments, it was not possible to manufacture shoes that, in addition to providing damping and support for the foot, also provide a comfortable climate for the foot. For example, the use of foamed plastic materials, which is common in modem sports shoes, prevents heat and humidity from being sufficiently transported away from the foot to efficiently avoid a hot feeling, an unpleasant odor, or a risk of diseases of the foot. These disadvantages present a severe problem in the case of sports shoes. Because of the increased physical activity during sporting activities, more heat and humidity arise in the foot area within the shoe. For this reason, there are different approaches to provide ventilation and removal of sweat from the foot area within the shoe.  \n           [0004]    For example, Swiss Patent No. 198 691 discloses an insole, wherein a leather sole provided with holes is arranged as a top layer on a frame-like supporting layer. The foot is to be surrounded by air from all sides to account purportedly for the breathing requirements of the foot sole. A similar construction is disclosed in United Kingdom Patent No. GB 2 315 010. Both Swiss Patent No. 198 691 and United Kingdom Patent No. GB 2 315 010 are hereby incorporated herein by reference. A disadvantage, however, is that no exchange takes place between the volume of air arranged below the foot sole and the surrounding air. As a result, humidity and bacteria can accumulate in the shoe.  \n           [0005]    Another approach is to connect an air volume, usually provided below the insole, with the outside air via lateral openings. The repeated compression of the shoe sole, a result of the action of the foot while running or walking, purportedly causes the warm air and humidity from the air volume inside the shoe to be pumped to the outside air with each step, thereby transporting humidity away. Examples of such shoes are disclosed in German Patent No. DE 121 957 and U.S. Pat. Nos. 5,035,068, 4,837,948, and 5,655,314, all of which are hereby incorporated herein by reference.  \n           [0006]    There are, however, problems with the foregoing concepts. First, the pumping action provided by the compression of the sole is too weak to assure a substantial exchange of air via the lateral openings, which may be several centimeters away. As such, the warm air and the humidity are only slightly moved back and forth without actually leaving the air volume from within the shoe. Second, a recess arranged below the insole, which contains the air volume, is so big that a soft shoe is created, which is mechanically unstable.  \n           [0007]    According to another concept, arrangements of partly closeable openings on a shoe upper can be used, examples of which can be found in U.S. Pat. Nos. 4,693,021, 5,357,689,and 5,551,172, all of which are hereby incorporated herein by reference. These arrangements do not have any influence on the aforementioned disadvantages, because the heat and humidity dispensed by the foot is predominantly arising in the foot sole area. As such, openings on the shoe upper do not significantly contribute to the ventilation of the foot sole area. Therefore, the arrangement of ventilation openings on the shoe upper does not result in a shoe that provides a comfortable and healthy foot climate.  \n           [0008]    Yet another approach is disclosed in U.S. Pat. No. 4,290,211, which is hereby incorporated herein by reference. Here, an outsole is perforated by a plurality of conically tapered openings and an insole has perforations that exactly coincide with the openings of the outsole. Although sufficient ventilation may be possible by this direct vertical connection from the foot sole to the outside, multiple through-holes reduce the mechanical stability of the sole, so only a few openings can be provided. This, however, reduces the desired ventilation effect. As a result, such a simple perforation of the shoe sole has not become popular, in particular in the case of sports shoes.  \n           [0009]    With the introduction of so-called \u201cclimate membranes,\u201d one example of which is the GORE-TEX\u00ae brand sold by W.L. Gore &amp; Associates, the holes in the outsole are covered by a breathable membrane. Such constructions can be found in International Patent Application Publication No. WO97/28711 and European Patent Application No. EP 0 956 789, which are hereby incorporated herein by reference. Although the use of climate membranes may lead to improved watertightness of the shoe, the above described disadvantages concerning the stability of the shoe are not overcome, but worsened, because even with a breathable membrane, more through-holes in the sole are necessary to assure sufficient ventilation of the foot sole.  \n           [0010]    Furthermore, International Patent Application Publication No. WO99/66812, European Patent Application No. EP 0 960 579, and U.S. Pat. Nos. 5,983,524 and 5,938,525, the disclosures of which are hereby incorporated herein by reference, disclose combinations of the above-described approaches, but without overcoming the respective disadvantages. In one example, the five-layer system disclosed in U.S. Pat. No. 5,983,525 consists of an outsole, a membrane, a protecting layer, a filling layer, and an insole with isolated arranged perforations in their respective layers. This system is far too dense for effective ventilation of the sole area, even if breathing active materials are used.  \n         SUMMARY OF THE INVENTION  \n         [0011]    The climate control shoe sole of the present invention overcomes the disadvantages of known sports shoes and methods for transporting heat and humidity from a wearer&#39;s foot. Generally, the sole, as described herein, assures a comfortable and healthy foot by providing proper ventilation and air exchange within the shoe, while at the same time preserving the mechanical stability required for sports shoes.  \n           [0012]    In one aspect, the invention relates to a sole for an article of footwear. The sole includes an insole layer with a plurality of first openings, a support layer with a plurality of second openings, and an outsole layer with at least one third opening. A substantial portion of the plurality of first openings in the insole layer are interconnected. The openings in each of the layers are arranged such that the second openings in the support layer partially overlap the first openings in the insole layer and the at least one third opening in the outsole layer partially overlaps the second openings in the support layer.  \n           [0013]    In another aspect, the invention relates to an article of footwear including an upper and a sole. The sole includes an insole layer with a plurality of first openings, a support layer with a plurality of second openings, and an outsole layer with at least one third opening. A substantial portion of the plurality of first openings in the insole layer are interconnected. The openings in each of the layers are arranged such that the second openings in the support layer partially overlap the first openings in the insole layer and the at least one third opening in the outsole layer partially overlaps the second openings in the support layer. In one embodiment, the upper is made of a reinforced mesh material. Optionally, the article of footwear can include a climate control sock that has a two layer mesh construction.  \n           [0014]    In various embodiments of the foregoing aspects of the invention, the plurality of first openings are distributed over substantially the entire insole layer and the first openings may be generally circularly shaped. In some embodiments, a first portion of the plurality of first openings are disposed in at least one of a ball region and a heel region of the sole and a second portion of the plurality of first openings are disposed in the remaining regions of the sole. The openings of the first portion may be smaller than the openings of the second portion. In one embodiment, the openings of the first portion are less than about 3 millimeters (mm) in diameter and the openings of the second portion are greater than about 4 mm in diameter. In other embodiments, at least one channel interconnects a portion of the first openings and the channel is disposed on a bottom side of the insole layer.  \n           [0015]    In some embodiments, the support layer is a substantially compression resistant semi-rigid chassis that controls deformation properties of the sole. The support layer may extend along a heel region and/or a ball region of the sole. In various embodiments, the plurality of second openings in the support layer may be disposed in a toe region and/or an arch region and/or an upwardly extending portion of the sole. In some embodiments, the plurality of second openings form a grill pattern. In other embodiments, the support layer may further include a support element disposed in the arch region of the sole. The support element interconnects a forefoot part and a rearfoot part of the sole, and the support layer and/or the support element may sideways encompass a wearer&#39;s foot in the arch region and/or the heel region of the sole.  \n           [0016]    In additional embodiments, the outsole layer of the invention may include a plurality of sole elements, for example a forefoot element and a rearfoot element. The outsole layer may extend along the heel region and/or the ball region of the sole. In various embodiments, the at least one third opening is disposed in the toe region and/or the arch region of sole and overlaps with corresponding second openings in the support layer. The outsole layer may also sideways encompass the wearer&#39;s foot in the heel region and/or a forefoot region of the sole. In other embodiments, the outsole layer further includes a cushioning layer and/or a tread layer.  \n           [0017]    In still other embodiments, the sole may include a membrane disposed between the support layer and the insole layer. In some embodiments, a shoe in accordance with the invention may include a flexible net-like element for selective reinforcement of parts of an upper. The flexible net-like element may be disposed in a heel region of the upper, for example, the medial and/or lateral side of a wearer&#39;s ankle.  \n           [0018]    These and other objects, along with advantages and features of the present invention herein disclosed, will become apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations. \n       \n    \n    \n     BRIEF DESCRIPTION OF THE DRAWINGS  \n       [0019]    In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:  \n         [0020]    [0020]FIG. 1A is an exploded isometric view of one embodiment of a sole in accordance with the invention;  \n         [0021]    [0021]FIG. 1B is an enlarged view of a portion of a support layer depicted in FIG. 1A;  \n         [0022]    [0022]FIG. 2 is a schematic plan view of one embodiment of an insole layer in accordance with the invention, as viewed from below;  \n         [0023]    [0023]FIG. 3 is a schematic bottom view of one embodiment of an assembled support layer and outsole layer in accordance with the invention;  \n         [0024]    [0024]FIG. 4 is a schematic side view of the assembled support layer and outsole layer of FIG. 3;  \n         [0025]    [0025]FIG. 5 is a schematic bottom view of another embodiment of an assembled support layer and outsole layer in accordance with the invention;  \n         [0026]    [0026]FIG. 6 is a schematic side view of the assembled support layer and outsole layer of FIG. 5;  \n         [0027]    [0027]FIG. 7 is a schematic bottom view of yet another embodiment of an assembled support layer and outsole layer in accordance with the invention;  \n         [0028]    [0028]FIG. 8 is a schematic side view of the assembled support layer and outsole layer of FIG. 7;  \n         [0029]    [0029]FIG. 9 is a schematic plan view of an embodiment of a net-like protection element in accordance with the invention;  \n         [0030]    [0030]FIG. 10 is a schematic side view of the net-like protection element of FIG. 9 used in accordance with the invention;  \n         [0031]    [0031]FIG. 11 is a schematic side view of one embodiment of an article of footwear in accordance with the invention;  \n         [0032]    [0032]FIG. 12 a  is a graph showing the humidity of a foot climate measuring sock in the interior of a shoe made in accordance with the invention; and  \n         [0033]    [0033]FIG. 12 b  is a graph showing the humidity of a foot climate measuring sock in the interior of a conventional shoe, as compared to the graph of FIG. 12 a.   \n     \n    \n     DESCRIPTION  \n       [0034]    Embodiments of the present invention are described below. It is, however, expressly noted that the present invention is not limited to these embodiments, but rather the intention is that modifications that are apparent to the person skilled in the art are also included. In particular, the present invention is not intended to be limited to sports shoes, but rather it is to be understood that the present invention can also be used to improve the foot climate of any article of footwear. Further, only a left or right sole and/or shoe is depicted in any given figure; however, it is to be understood that the left and right soles/shoes are typically mirror images of each other and the description applies to both left and right soles/shoes.  \n         [0035]    Generally, a sole in accordance with the invention includes at least three layers that may include several function specific components. Each of the layers has one or more openings disposed therein, such that ventilation and air exchange may occur within the shoe, thus improving the climate properties of the shoe. The one or more openings in each layer partially overlap the openings in the adjacent layer when the shoe sole is fully assembled. By the arrangement of the three or more layers with openings that only partially overlap, a substantially greater number of openings can be provided in the insole layer without reducing the mechanical stability of the shoe. As a result, the heat and humidity generated can be removed directly from the foot sole much more quickly than with conventional shoe designs.  \n         [0036]    A sole  100  in accordance with the invention is shown in FIG. 1. The sole  100  includes a support layer  10  arranged below an insole layer  1  and an outsole layer  30  arranged below the support layer  10 . The insole layer  1  includes a plurality of openings  2 ,  3  and can act as a cushioning layer for the sole  100 . The support layer  10  may be reinforced from below by a support element  20 . Alternatively, the support layer  10  may include a plurality of support elements  20  located at various locations along the sole  100 . The outsole layer  30  shown includes a forefoot part  31  and a rearfoot part  32 . Alternatively, the outsole layer  30  may include additional sole elements. A tread layer  40  may be provided directly below the outsole layer  30  to improve traction. The tread layer  40  includes a front part  41 , which corresponds to the forefoot part  31  of the outsole layer  30  and a rear part  42  that corresponds to the rearfoot part  32  of the outsole layer  30 . The outsole layer  30  may also include a cushioning layer  70 . FIGS. 3 and 4 depict the sole  100  assembled, as indicated by the dashed arrows in FIG. 1. In addition, an upper  102  of a shoe  101  can be attached to the sole  100 , as best seen in FIG. 11.  \n         [0037]    The insole layer  1  is depicted in FIG. 2 and includes a plurality of generally circularly shaped openings  2 ,  3 . Alternatively, the openings  2 ,  3  may have a shape other than circular, for example square, rectangular, elliptical, or any combination thereof. The openings  2 ,  3  may be distributed over substantially the entire area of the insole layer  1 . Generally, the openings  3  have a greater open area than the openings  2  to optimize the permeability of the insole layer  1  for air and humidity transfer. Further, in order to avoid excessive local pressure on the foot sole and at the same time provide adequate ventilation, the openings  2  of the insole layer  1  are preferably smaller in the heel region  6  and/or the ball region  7  of the insole layer  1 . In one embodiment, the diameter of the openings  2  in these regions is only about 2 mm to about 3 mm, whereas the diameter of the openings  3  in the remaining regions of the insole layer  1  is about 4 mm to about 5 mm. In other embodiments, the openings  2  located in the heel region  6  and/or the ball region  7  may be substantially smaller than the openings  3  located in other regions of the sole.  \n         [0038]    The openings  2 ,  3  are interconnected on a bottom side  14  of the insole layer  1  by at least one channel. In the embodiment shown, a plurality of channels  4 ,  5  are used. The channels  4 ,  5  can be arranged on the top side  15  or the bottom side  14  of the insole layer  1  or can even be integrated into the insole layer  1 . It has been found, however, that in order to avoid excessive friction between the foot sole and the insole layer  1 , and for reasons associated with the manufacture of the insole layer  1 , an arrangement on the bottom side  14  is typically beneficial. In one embodiment, most of the larger openings  3  are connected to their respective next opening  3  only by a single channel  5  and the smaller openings  2  are interconnected by a grid-like pattern of crossing channels  4 . Not all openings  2 ,  3  need to be connected to other openings  2 ,  3 .  \n         [0039]    The insole layer  1  can be manufactured by, for example, injection molding or extrusion. Extrusion processes may be used to provide a uniform shape. Insert molding can then be used to provide the desired geometry of the open spaces, or the open spaces could be created in the desired locations by a subsequent machining operation. The insole layer  1  can be manufactured from any suitable polymeric material or combination of polymeric materials, either with or without reinforcement. Suitable materials include polyurethanes (PU), such as a thermoplastic polyurethane (TPU), ethylene vinyl acetate (EVA), or other comparatively soft material. Other suitable materials will be apparent to those skilled in the art.  \n         [0040]    By the repeated compression of the insole layer  1  from the mechanical loading of the shoe  101  during ground contact, a pumping action is caused, which quickly transports the humidity surrounding the foot sole down to the support layer  10 . For example, in the case of extreme physical activity, such as during a basketball game, hot and humid air develops below the foot sole in the interior of the shoe. In shoe soles  100  according to the present invention, the hot and humid air is transported through the openings  2 ,  3  down to the support layer  10 . The network of channels  4 ,  5  arranged on the bottom side  14  of the insole layer  1  allow a fast horizontal diffusion of the humidity to the adjacent openings  11 ,  12  in the support layer  10 . This diffusion is facilitated by the repeated compression of the channels  4 ,  5  on the bottom side  14  of the insole layer  1 , which act as small pumps.  \n         [0041]    Referring to FIGS. 1, 3, and  4 , the support layer  10 , together with the additional support element  20 , forms a frame or chassis around which the shoe  101  is built. The support layer  10 , in part, determines the mechanical properties of the shoe in which it is used, such as the response of the shoe to loads arising during a particular sport. The support layer  10  includes a forefoot part  21  having a generally planar shape and a rearfoot part  22  that three-dimensionally encompasses the heel of a wearer&#39;s foot, thereby providing support. In one particular embodiment, the support layer  10  extends into the heel region  6  and the ball region  7  of the sole  100  to withstand particularly high mechanical loading on shoes in these areas during repeated ground contact and push-off motions. In addition, a plurality of openings  11  can be arranged in the toe region  9  and/or the arch region  8  of the sole  100  so as not to degrade the support provided by the support layer  10 . Additional longitudinal supports  13  can be used to reinforce the stability of the support layer  10  in the toe region  9 , and struts  14  can be used to reinforce the support layer  10  in the arch region  8 . In addition, lateral flanges  24  can be provided on the support layer  10  with openings  12  to contribute to ventilation of the interior of the shoe  101 .  \n         [0042]    The openings  11 ,  12  are formed by a series of closely spaced, generally parallel bands or ribs  27  that form a grill or cage pattern and provide a moisture and air pervious structure. As best seen in FIG. 1B, the ribs  27  are generally circularly shaped and have a diameter of about 1 mm to about 2 mm and a spacing of about 2 mm to about 3 mm. The grill pattern is used to achieve a very low resistance to the flow of humidity and hot air while also maintaining the greatest stability of the sole  100 . Alternatively, the openings  11 ,  12  could be circular, rectangular, elliptical, or any combination thereof. The distribution of the openings  11 ,  12  may affect the mechanical properties of the support layer  10 . For example, in one embodiment of the sole  100 , no openings are provided in the heel region  6  and the ball region  7  of the sole  100 , because these two regions of the sole  100  require a high degree of support in order to avoid excessive pronation or supination of the wearer&#39;s foot.  \n         [0043]    When the insole layer  1  is arranged on top of the support layer  10 , the hot and humid air coming down through the openings  2 ,  3  can pass through the openings  11 ,  12  in the support layer  10 . The majority of the openings  2 ,  3  in the toe region  9  and the arch region  8  directly overlap with the openings  11 ,  12  of the support layer  10 . The greatest density of the foot&#39;s sweat pores are located in the toe region  9  and the arch region  8  of the wearer&#39;s foot, therefore, openings in the sole  100  corresponding to those regions furthers the downward guidance of the hot and humid air. The humidity developing in the heel region  6  and the ball region  7  is at first \u201cpumped\u201d through the channels  4 ,  5  along the bottom side  14  of the insole layer  1 , i.e., along the upper side of the support layer  10 , until the closest opening  11 ,  12  in the support layer  10  is reached.  \n         [0044]    The support layer  10  can be manufactured by, for example, injection molding or extrusion. Extrusion processes may be used to provide a uniform shape, such as a single monolithic frame. Insert molding can then be used to provide the desired geometry of the open spaces, or the open spaces could be created in the desired locations by a subsequent machining operation. Other manufacturing techniques include melting or bonding portions together. For example, the lateral flanges  24  may be adhered to the support layer  10  with a liquid epoxy or a hot melt adhesive, such as (EVA). In addition to adhesive bonding, portions can be solvent bonded, which entails using a solvent to facilitate fusing of the portions.  \n         [0045]    The support layer  10  can be manufactured out of substantially compression resistant plastic materials, which have the advantage of withstanding the mechanical loads arising during contact of the shoe with the ground and also have the required flexibility not to hinder movements of the foot, such as those that occur during the rolling-off and pushing-off phase of the gait cycle. In particular, the support layer  10  can be manufactured from any suitable polymeric material or combination of polymeric materials, either with or without reinforcement. Suitable materials include: polyurethanes, such as a thermoplastic polyurethane (TPU); EVA; thermoplastic polyether block amides, such as the Pebax\u00ae brand sold by Elf Atochem; thermoplastic polyester elastomers, such as the Hytrel\u00ae brand sold by DuPont; polyamides, such as nylon  12 , which may include 10 to 30 percent or more glass fiber reinforcement; silicones; polyethylenes; and equivalent materials. Reinforcement, if used, may be by inclusion of glass or carbon graphite fibers or para-aramid fibers, such as the Kevlar\u00ae brand sold by DuPont, or other similar method. Also, the polymeric materials may be used in combination with other materials, for example rubber. Other suitable materials will be apparent to those skilled in the art. The specific materials used will depend on the particular application for which the shoe is designed, but generally should be sufficiently compression-resistant, supportive, and flexible to the extent necessary for a particular sport.  \n         [0046]    The support layer  10  can be reinforced by a support element  20  disposed in the arch region  8  of the sole  100 . The support element  20  can be an open frame construction with a plurality of openings  23 , which may correspond to the openings  11 ,  12  and the struts  14  of the support layer  10 . The support element  20  can affect the resistance of the sole  100  to foot movements, for example torsional movements of the forefoot with respect to the rearfoot. The support element can also control the longitudinal stiffness of the shoe  101 . The exact configuration of the support layer  10  and support element  20  can be varied to accommodate numerous applications. For example, different embodiments of the support layer  10  and/or the support element  20  will be used to customize the sole  100  and/or the shoe  101  for a particular activity. In addition, the support element  20  may be secured to the support layer  10  by adhesive bonding, solvent bonding, mechanical retention, or similar techniques. Various alternative embodiments of the support layer  10 ,  110 ,  210 , the support element  20 ,  120 ,  220 , and the outsole layer  30 ,  130 ,  230  are schematically illustrated in FIGS.  5  to  8 .  \n         [0047]    The support element  20  can be manufactured in any of the manners and materials as described hereinabove for the support layer  10 . Although in the embodiment shown in FIG. 1, the support layer  10  and the support element  20  are shown as separate components of the sole  100 , an integrated alternative is possible. For example, the support layer  10  and any support elements  20  can be produced as an integral component by dual injection molding.  \n         [0048]    Referring again to FIGS. 1, 3, and  4 , the outsole layer  30  is positioned below the support layer  10  and any additional support elements  20 . In the embodiment shown in FIG. 1, the outsole layer  30  includes a forefoot part  31  and a rearfoot part  32 . The weight of the shoe  101  is reduced by the absence of any outsole material in the arch region  8  of the sole  100 . In addition, large recesses or openings  33 ,  34 ,  35  are disposed in the outsole layer  30  to facilitate the dispersion of the hot and humid air from the interior of the shoe  101  via the openings  11 ,  12  in the support layer  10  to the outside air. Essentially, the openings  33 ,  34 ,  35  do not affect the damping properties of the outsole layer  30 . The openings  33 ,  34 ,  35  are positioned such that they generally correspond with the openings  11 ,  12  of the supporting layer  10 ; however, the openings  33 ,  34 ,  35  can be positioned to accommodate a particular application.  \n         [0049]    Because of the thickness of the outsole layer  30 , which is in the range of about 0.5 centimeters (cm) to about 2 cm, the openings  11 ,  12  of the support layer  10  are not in direct contact with the ground. Accordingly, this prevents humidity (water vapor and/or fluid) from easily entering the interior of the shoe  101 . If the shoe  101  is not used exclusively for indoor sports, then a breathable membrane  26  can be provided for complete watertightness. The breathable membrane  26  may be positioned between the support layer  10  and the insole layer  1 . The breathable membrane  26  may be made out of a breathable, but watertight, material that may further improve the climate properties of the shoe  101 , for example the GORE-TEX\u00ae brand sold by W.L. Gore &amp; Associates. The sole  100  includes enough openings arranged above and below the membrane  26  that the breathing properties of the membrane  26  are effective without endangering the overall stability of the shoe  101 . Furthermore, the grill-like openings  11 ,  12  of the support layer  10  protect the membrane  26  against damage from below. Further, the membrane  26  prevents stones or dirt from entering the interior of the shoe  101  and, thereby prevents deterioration of the ventilation properties of the shoe  101  by clogged or closed openings.  \n         [0050]    In the case of sports with high lateral loading, for example basketball, the outsole layer  30  can extend upwards over the edge of the sole  100 , as shown in FIG. 4. Such an arrangement cushions against lateral ground contacts. In addition, the flexibility of the outsole layer  30  can be improved by strategically positioning one or more grooves  36  in the outsole layer  30 , for example to facilitate an easier rolling-off phase of the gait cycle. FIGS.  5  to  8  depict alternative embodiments of the outsole layer  30 ,  130 ,  230 . In the case of a sport such as tennis, which requires a high degree of lateral stability due to strong lateral loading, the embodiment shown in FIG. 5 may be used advantageously.  \n         [0051]    The traction properties of the sole  100  may be enhanced by the addition of a tread layer  40  below the outsole layer  30 . Depending on the particular application, different materials can be used, such as TPU or suitable rubber mixtures that simultaneously provide high abrasion resistance and good traction. The shape of the tread layer  40  typically corresponds to the outsole layer  30  so that the ventilation properties of the sole  101  are not affected by the function specific selection of a suitable tread layer  40 . The tread layer  40  can also extend sideways over the edge of the sole  100  to improve grip during lateral ground contact of the foot. Additionally, the outsole layer  30  can include a cushioning layer  70  to enhance the damping properties of the sole  100 .  \n         [0052]    The outsole layer  30 , the tread layer  40 , and the cushioning layer  70  can be manufactured by any of the methods disclosed herein. In addition, the outsole layer  30 , the tread layer  40 , and the cushioning layer  70  can be manufactured from any of the materials described herein to suit their particular application. For example, the arrangement and materials used in the outsole layer  30  can affect the damping properties of the shoe  101 . As such, foamed materials, such as PU, EVA, and like elastomeric materials, are recommended. These materials are subjected to a strong compression set during the course of their manufacture, such that they permanently keep their elastic damping properties even under high mechanical loading. With respect to the cushioning layer  70 , comparatively soft materials, such as PU or EVA, are recommended.  \n         [0053]    Athletic shoes used in sports with many jumps and frequent changes of direction, for example basketball, typically extend upwards over the ankle joint to support the joint and protect against injuries. In one embodiment, the shoe  101  includes a flexible net-like protection element  60 , which is shown in FIG. 9 in an unfolded position and in FIG. 10 in its position proximate the ankle area  62  of the shoe  101 . In the finished shoe  101 , the element  60  is typically covered by a suitable air permeable fabric or mesh.  \n         [0054]    The protection element  60  is made out of a flexible material, for example EVA or a material based on a silicone elastomer. Alternatively, other soft thermoplastic materials or a PU can be used. The protection element  60  is manufactured in a generally planar configuration and is folded or otherwise manipulated into shape and then secured in place within the shoe  101 . Alternatively, the protection element  60  can be directly three-dimensionally shaped, for example by injection molding or other suitable techniques, and then bonded to the shoe  101  and/or sole  100 . The protection element  60  includes a plurality of openings  61  that improve the air permeability of this area of the shoe  101 . The shape and dimensions of the openings  61  will vary to suit a particular application. The dimensions are in the range of about 2 mm to about 4 mm, up to about 1 cm. The shape of the openings  61  can be circular, rectangular, elliptical, or any combination thereof. In the embodiment shown on FIGS. 9 and 10, the openings  61  have an essentially rectangular shape. The protection element  60  provides good support and protection for the ankle joint, as well as improved ventilation of the interior of the shoe  101 , because it replaces commonly used denser materials. Similar protection elements can also be used in other parts of the upper  102 , for example in the instep region  64  where excessive pressure may be caused by a lacing system  65  (FIG. 11) of the shoe  101 , without reducing the air permeability of the upper  102 .  \n         [0055]    [0055]FIG. 11 depicts a shoe  101  and sock  103  assembly according to one aspect of the invention. The shoe  101  includes an upper  102  and a sole  100  in accordance with the invention. The upper  102  can be a reinforced mesh material that includes bands or members  108  that are anchored to the sole  100 . The members  108  can provide the structural support for the lacing system  65 . The upper  102  can be attached to an edge of the sole&#39;s support layer  10  by gluing, stitching, or other suitable techniques. Alternatively, the upper  102  can be any known type or configuration of an upper. The upper  102  shown includes a lacing system  65 , which can be any conventional lacing system, such as laces or a hook and loop type fastener, such as the Velcro\u00ae brand sold by Velcro Industries B.V. The special sock  103  functions to improve the climate properties of the shoe  101  when used in combination with the sole  100 . The sock  103 , together with the sole  100 , forms an overall system that determines the thermophysiological conditions a foot is subjected to. These conditions are defined by the heat and steam transmission resistances, the steam or water absorption/emission, and the friction forces of the surfaces of the sock and the shoe.  \n         [0056]    In one embodiment, the sock  103  includes a two layer mesh construction having an inside layer  104  with good diffusion properties and an outsole layer  105  with good absorption properties. The good diffusion properties of the insole layer  104  cause the sweat generated by the foot to be immediately transferred away from the skin to the outer layer  105 , for example by capillary wicking. The outside layer&#39;s good absorption properties act as a storage for the humidity before it is transported to the ambient air through the openings in the layers of the sole  100 . These particular properties of the sock  103  can be achieved by using synthetic fiber materials, such as the Polycolon\u00ae brand sold by Sch\u00f6ller, the Dacron\u00ae brand sold by DuPont, or the Rhoa\u00ae-Sport brand sold by Rhodia.  \n         [0057]    A shoe in accordance with the invention was compared to a conventional shoe, the results of which are represented by the graphs shown in FIGS. 12 a  and  12   b . As can be seen, the shoe in accordance with the invention has substantially improved ventilation properties as compared to the conventional shoe. The testing was performed using a foot climate measuring sock, which made it possible to determine how fast humidity developing in the interior of the shoe is transported to the outside through the sole and the upper. A foot climate measuring sock is a cotton or polyester sock provided with capacitive sensors for measuring humidity and additional sensors for measuring temperature. Since the sensors are very thin, they are not felt by the wearer of the sock. The data measured by the sensors is sent to a personal computer where the humidity and temperature results are analyzed.  \n         [0058]    [0058]FIG. 12 a  shows the measurements taken during an approximately twenty-five minute test on a tread mill with a person wearing a shoe in accordance with the invention. The results are plotted on a graph where the Y-axis represents the Humidity Index as measured in millivolts (mV) and the X-axis represents the length of the test as measured in hours, minutes, and seconds. The increase in humidity in the interior of the shoe is reflected in the increasing voltage plotted along the Y-axis and represented as  110 . The graph represents a slow, generally linear increase from approximately 170 mV to approximately 400 mV, i.e., an increase of about 330 mV over a period of about twenty-five minutes.  \n         [0059]    [0059]FIG. 12 b  depicts the results of the same experiment, but performed with a person wearing a conventional sports shoe. Note the scaling of the Y-axis is different in the graph shown in FIG. 12 b  than in FIG. 12 a . Accordingly, to best illustrate the significant improvement of the inventive shoe, the voltage plot  110  of FIG. 12 b  is manually overlaid on the graph of  12   b . As can be seen, the voltage  120 , which is proportional to the humidity in the interior of the conventional shoe, rises rapidly from approximately 150 mV to approximately 800 mV, i.e., an increase of about 650 mV over a similar twenty-five minute period. Therefore, shoes in accordance with the invention reduce the increase in humidity in the shoe interior by almost 100% with respect to conventional shoes. This result corresponds to reports by test subjects who noticed the improved foot climate properties of the inventive shoes, as compared to the conventional shoes.  \n         [0060]    Having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The described embodiments are to be considered in all respects as only illustrative and not restrictive.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["A dental floss apparatus generally comprising a thimble, a pair of tines extending from the top surface of the thimble and a section of dental floss suspended between the tips of the tines. To floss, a forefinger or thumb is typically inserted into the thimble, which remains relatively fixed onto the forefinger or thumb by pressing the opposing forefinger or thumb on the same hand onto the side of the thimble. The thimble is sized and configured such that insertion of the forefinger or thumb causes a suction within the thimble that further aids holding the thimble. The section of dental floss across the tips is used to floss between the teeth. In an alternate configuration, a single tine extends upward from said thimble and dental floss is suspended between the tip of the tine and the thimble. In still another configuration, a second thimble is attached in tandem onto the first thimble for additional torque control. In lieu of the second thimble, a finger holder is attached in tandem onto the first thimble for torque control."], "input": "CROSS-REFERENCE TO RELATED APPLICATIONS \n     Not Applicable \n     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT \n     Not Applicable \n     REFERENCE TO A MICROFICHE APPENDIX \n     Not Applicable \n     BACKGROUND OF THE INVENTION \n     1. Field of the Invention \n     This application pertains generally to dental hygiene and more particularly to a one-piece disposable apparatus for teeth flossing. \n     2. Description of the Background Art \n     Dental flossing is an often unpleasant but necessary routine for good oral hygiene. The conventional method for flossing teeth involves grasping opposite ends of a length of dental floss with each hand, and manually manipulating the floss back and forth between the teeth. Anyone who has performed this arduous, but necessary, task is well aware that the nature of dental floss inherently makes it difficult to securely grasp and tautly hold a tensioned strand while maneuvering and manipulating the suspended section between all the teeth in an effort to floss. The smoothness of the floss, in addition to the saliva, prevents the fingers and hand from getting a secure grip, so the ends of the floss are usually wrapped around the fingers to maintain tautness. Those who have flossed in this conventional manner are aware that a tightly wrapped finger is uncomfortable, if not downright painful. Often the wrapped fingers turn purplish and begin to numb due to a lack of blood flow. Such inconveniences and difficulties spurred the development of various means to hold the dental floss while teeth flossing. \n     To alleviate such problems, means were developed to hold the dental floss while flossing. One such means is to provide short sections of approximately 41/2 inches of floss having stub sections or gripper handles at both ends of the floss section. Dental floss having gripper handles is taught in U.S. Pat. No. 4,016,892, which is incorporated herein by reference. \n     Another known means developed to hold dental floss included a pair of sleeves fitted over the fingertips. One sleeve serves as the supply sleeve containing pre-wound floss, and the other sleeve serves as the take-up sleeve for receiving spent floss. To floss, both fingers are inserted into the mouth with the sleeves fitted thereon and the section of floss suspended between the sleeves is used to floss between teeth. \n     The problem common to both of the foregoing flossing devices is that at least two fingers must be inserted into the mouth, especially when flossing between the rear molars. This often proves to be unwieldy and cumbersome as the mouth must be opened widely to allow insertion of the fingers therein. \n     There are presently no known one-piece disposable dental flossers which can floss teeth using only one finger inserted into the mouth. Accordingly, there is a need for a low cost disposable dental flosser which is capable of one-finger dental flossing. The present invention satisfies this need, as well as others, and overcomes the deficiencies found in the prior art. \n     BRIEF SUMMARY OF THE INVENTION \n     The present invention is a dental floss apparatus generally comprising a thimble, a pair of tines extending from the top of the thimble and a section of dental floss suspended across the tips of the tines. To floss, a forefinger or thumb is typically inserted into the thimble, which remains relatively fixed onto the forefinger or thumb by pressing the opposing forefinger or thumb on the same hand onto the side of the thimble. The thimble is sized and configured such that insertion of the forefinger or thumb causes a suction within the thimble that further aids holding the thimble. The section of dental floss across the tips is used to floss between the teeth. \n     In an alternate configuration, a single tine extends from the top of the thimble and a section of dental floss is suspended from the tip of the tine to the thimble. In the alternate configuration, the effective flossing length of the floss if increased and this embodiment is particularly well suited to flossing rear molars. In still another configuration, a second thimble is attached in tandem onto the first thimble for additional torque control. In lieu of the second thimble, a finger holder is attached in tandem onto the first thimble for torque control. \n     An object of the invention is to provide a dental floss apparatus that eases dental flossing by relieving the discomfort of wrapping dental floss around the fingers. \n     Another object of the invention is to provide a single use disposable dental floss apparatus that is inexpensive and easy to manufacture. \n     Still another object of the invention is to provide a one-piece dental floss apparatus which is placed on only one finger or thumb, thus requiring insertion of only the finger or thumb into the mouth for flossing. \n     Further objects and advantages of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon. \n    \n    \n     BRIEF DESCRIPTION OF THE DRAWINGS \n     The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only: \n     FIG. 1 is a front view of a dental flossing apparatus in accordance with the present invention. \n     FIG. 2 is a side view of the dental flossing apparatus shown in FIG. 1. \n     FIG. 3 is a front view of an alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 4 is a fragmentary detail view of the tine portion of the apparatus shown in FIG. 3. \n     FIG. 5 is a front view of a second alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 6 is a fragmentary detail view of the tine portion of the apparatus shown in FIG. 5. \n     FIG. 7 is a side view of a third alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 8 is a front view of a the dental flossing apparatus shown in FIG. 7. \n     FIG. 9 is a front view of a fourth alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 10 is a side view of a dental flossing apparatus shown in FIG. 9. \n     FIG. 11 is a front view of a fifth alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 12 is a front view of a sixth alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 13 is a side view of a dental flossing apparatus shown in FIG. 12. \n     FIG. 14 is an exploded view of a dental flossing apparatus shown in FIG. 12. \n     FIG. 15 is an exploded front view of a seventh alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 16 is a front view of an eighth alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n     FIG. 17 is a side view of a dental flossing apparatus shown in FIG. 16. \n     FIG. 18 is a front view of a ninth alternative embodiment of a dental flossing apparatus in accordance with the present invention. \n    \n    \n     DETAILED DESCRIPTION OF THE INVENTION \n     Referring more specifically to the drawings, for illustrative purposes the present invention is embodied in the apparatus generally shown in FIG. 1 through FIG. 18, wherein like reference numerals denote like parts. It will be appreciated that the apparatus may vary as to configuration and as to details of the parts without departing from the basic concepts as disclosed herein. \n     Referring to FIG. 1 and FIG. 2, a finger flossing apparatus 10 in accordance with the present invention is generally shown. Apparatus 10 generally comprises a thimble 12, a pair of tines 14a, 14b extending from the distal end 16 of thimble 12, and a section of dental floss 18 is horizontally suspended between the tips 20a, 20b of tines 14a, 14b, respectively. Tines 14a, 14b can be configured to either be straight, or curved as shown in FIG. 2, and are typically about 3/4 inches long. \n     Thimble 12 has an opening 22 sized and configured to receive the tip of a finger or thumb therein. The wall 24 of thimble 12 is preferably distally tapered to generally match a fingertip&#39;s profile, and distal end 16 of thimble is generally convex. Thimble 12 can be sized to accommodate all the varying finger sizes from children to adults, and thimble 12 is preferably fabricated from an elastic material, such as rubber, ABS plastic or polypropylene, to better conform to the fingertip of the user and to provide a better grip when worn. Where a collapsible elastic material is used, a band 26 is provided around opening 22 to hold open and facilitate placement of apparatus 10 over the tip of the finger or thumb, much like a finger cot. \n     Dental floss 18 is preferably fabricated from puffed Teflon\u2122 or other similarly tough floss material. However, those skilled in the art will appreciate that use of apparatus 10 can be practiced with any type of dental floss. Dental floss 18 is permanently affixed at points 28a, 28b adjacent tips 20a, 20b of tines 14a, 14b during manufacturing by an injection molding process that also forms thimble 12 and tines 14a, 14b of apparatus 10. In this embodiment, tines 14a, 14b can either be rigid or semi-rigid. Apparatus 10 manufactured in this manner is a single-use disposable article. \n     To use apparatus 10 for flossing teeth, thimble 12 is inserted over the tip of any finger or thumb. Since some manipulation of the finger or thumb within the mouth is necessary during flossing with apparatus 10, the preferred finger used for flossing with apparatus 10 is the index finger, as most users have better control of their index fingers. Thimble 12 is sized such that a fairly tight fit results with the finger is inserted therein, and the elasticity of thimble 12 serve to better grip thimble around the tip of the finger. A vacuum is also created after insertion of the finger into thimble 12, which further aids in securely holding thimble 12 onto the finger or thumb. Once thimble 12 is in place over the finger or thumb tips, apparatus 10 is maneuvered within the mouth so that dental floss 18 can be slid between teeth for flossing action. \n     Various other means for supporting dental floss 18 on thimble 12 are also contemplated. These alternative attachment means provide for the removal and replacement of dental floss 18, thus rendering apparatus 10 reusable. For example, as shown in FIG. 3 through FIG. 6, an alternative embodiment and a second alternative embodiment of apparatus 10 is generally shown. Dental floss 18 can include gripper handles 30a, 30b as shown in FIG. 3 or gripper handles 32a, 32b, as shown in FIG. 5 and FIG. 6, which are disposed at each end of the dental floss as taught in U.S. Pat. No. 4,016,892, which is incorporated herein by reference. The gripper handles can be spherical as shown in FIG. 3, elongated as shown in FIG. 5 and FIG. 6, or any other shape (e.g., hex, triangular, star-shaped, etc.) that is desired and convenient for attachment and use. \n     To accommodate dental floss 18 having gripper handles, a channel or slot 34a, 34b is disposed adjacent each tip 20a, 20b of tines 14a, 14b. Each slot 34a, 34b preferably has an opening 36a, 36b for the insertion of dental floss 18 therein. Slots 34a, 34b and openings 36a, 36b are sized to receive and allow passage of dental floss 18 therethrough. To prevent dental floss 18 from slipping off during flossing, slots 34a, 34b preferably follow an arced or curvilinear path from openings 36a, 36b to receptacles 38a, 38b, respectively, which receive the gripper handles. In the embodiments shown, receptacles 38a, 38b are semi-spherical depressions to receive spherical gripper handles, but it will be appreciated that neither the shape of the gripper handles nor that of the receptacles is limited. \n     In the embodiment shown in FIG. 3, tines 14a, 14b are preferably sufficiently flexible that they can be flexed toward each other for attachment of dental floss 18, and dental floss 18 preferably has a length slightly less than the distance between tips 20a, 20b when tines 14a, 14b are in a relaxed position (no floss installed). Receptacles 38a, 38b are sized to be smaller than gripper handles 30a, 30b to prevent passage of gripper handles 30a, 30b therethrough. As dental floss 18 is placed in receptacles 38a, 38b, tines 14a, 14b are flexed toward each other. The tendency for tines 14a, 14b to return to their relaxed position serves to maintain constant tautness on dental floss 18 necessary for flossing. \n     In the second alternative embodiment shown in FIG. 5 and FIG. 6, gripper handles 32a, 32b are inserted into receptacles 40a, 40b, respectively, as shown. Receptacles 40a, 40b are disposed on wall 24 of thimble 12 below tines 14a, 14b, respectively. Receptacles 40a, 40b are sized to snugly receive gripper handles 32a, 32b therein and to securely maintain said handles in place during flossing. The length of dental floss 18, in conjunction with the position of receptacles 40a, 40a provides for tautness of dental floss 18 when placed on apparatus 10. It will be appreciated that the means for suspending dental floss between the tines shown in FIG. 3 and FIG. 4 and between the tine and the thimble shown in FIG. 5 and FIG. 6 could be combined. For example, a hybrid could be configured where one gripper handle is retained by the tip of a tine as in FIG. 3, while the other gripper handle fits into a receptacle in the thimble as shown in FIG. 6. \n     Referring also to FIG. 7 and FIG. 8, a third alternative embodiment 42 of the present invention is generally shown wherein still another means for supporting dental floss 18 from thimble can be seen. A single tine 14a extends from the distal end 16 of thimble 12 and dental floss 18 is suspended between tip 20a of tine 14a and thimble 12. Tine 14a is typically angled or curved, as shown in FIG. 7, to better allow for the vertical suspension of dental floss 18, and is preferably centered as shown in FIG. 8. \n     Dental floss 18 can be attached to either wall 24 or distal end 16 of thimble 12. Dental floss 18 is preferably fixedly attached to both tip 20a of tine 14a and thimble 12 during manufacture by an injection molding process. This embodiment is particularly well suited to flossing anterior teeth such as rear molars. It will also be appreciated that, as an alternative, dental floss with gripper handles could be used. Here, the tip of the tine would be configured similarly to that shown in the alternative embodiment of FIG. 3 and FIG. 4, and the receptacle in the thimble would be like that shown in second alternative embodiment of FIG. 6. \n     Referring now to FIG. 9 and FIG. 10, a fourth alternative embodiment of a dental flossing apparatus is generally shown. Here, a second thimble 46 is used in conjunction with thimble 12 to allow for additional torque control and leverage during flossing. Second thimble 46 is placed in tandem with thimble 12 and connected thereto by a bridge 48. Second thimble includes an opening 50, a band 52 peripherally disposed around opening 50, a tapered wall 54 extending from opening 50 and a convex-shaped distal end 56. Bridge 48 is attached to wall 24 of thimble 12 and wall 54 of second thimble 46. Tines 14a, 14b is fixedly attached and extends from distal end 16 of thimble 12, as also shown in the first embodiment. It is also contemplated that tines 14a, 14b can extend from distal end 56 of second thimble 46. It is further contemplated that tine 14a may extend from thimble 12 while tine 14b may extend from second thimble 46. Tines 14a, 14b are formed with thimbles 12, 46 during manufacturing preferably by an injection molding process. The additional of second thimble 46 in tandem to thimble 12 permits two adjacent fingers to be used to floss which increases the user&#39;s torque control and leverage especially when flossing hard to reach areas within the mouth. \n     Referring also to FIG. 11, a fifth alternative embodiment 58 of a dental flossing apparatus is generally shown. In this embodiment, a finger holder 60 is attached in tandem to thimble 12 by bridge 48. Finger holder 60 comprises a semi-circular member having a tapered wall 62 that extends to a cover 64 located adjacent its distal end 66 longitudinally separated approximately adjacent its midpoint. Cover 64 and wall 62 form a void (not shown) configured to receive and hold a finger therein. Finger holder 60 increases the user&#39;s torque control and leverage. \n     In FIG. 12 through FIG. 14, a sixth alternative embodiment 68 of a dental flossing apparatus is generally shown. Tines 14a, 14b are part of a tine assembly 70 that is detachable from thimble 12. Assembly 70 comprises a cross-member 72 connecting tines 14b, 14b together in a generally parallel fashion. A pair of legs 74a, 74b extend downwardly from cross-member 72. Legs 74a, 74b each includes a tang 76a, 76b, respectively, at their lower end, which is adapted to slidably engage within a pair of longitudinally-disposed grooves 78a, 78b along wall 42 of thimble 12. Grooves 78a, 78b are spaced approximately 180\u00b0 apart and extend downward from distal end 16 of thimble 12 to approximately the mid-section of thimble 12. A pair of recesses 80a, 80b are located within grooves 78a, 78b, respectively to serve as anchor points for tangs 76a, 76b. Legs 74a, 74b are somewhat flexible and naturally spaced such that when tangs 76a, 76b are inserted into respective recesses 80a, 80b, legs 74a, 74b exert pressure on wall 24 of thimble 12 to help maintain tangs 76a, 76b within recesses 80a, 80b, during stresses encountered by dental floss 18 during flossing. It is contemplated that recesses 80a, 80b can be also located on wall 54 of second thimble 46, providing the user the option of which thimble to place tine assembly 70 upon. \n     In FIG. 15, a seventh alternative embodiment 82 of a dental flossing apparatus is generally shown. Tine assembly 70 is adapted to attach onto thimble 12 which includes finger holder 60 tandemly attached thereto. The configuration and benefits provided by finger holder is discussed above with respect to fifth alternative embodiment 58. \n     Referring to FIG. 16 and FIG. 17, an eighth alternative embodiment 84 of a dental flossing apparatus is generally shown. Dental floss 18 is attached onto thimble 12 by single tine 14a, and second thimble 46 is tandemly attached to thimble 12 by bridge 48. \n     In FIG. 18, a ninth alternative embodiment 86 of a dental flossing apparatus is generally shown. In addition to dental floss 18 attached to thimble 12 by single tine 14a, finger holder 60 is tandemly attached to thimble 12. \n     Accordingly, it will be seen that this invention eliminates the problems commonly associated with flossing teeth by using a teeth flossing apparatus that is placed over the tip of a finger or thumb. Although the description above contains many specificities, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Thus the scope of this invention should be determined by the appended claims and their legal equivalents.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["A method for simulating a blood flow in a vascular segment of a patient is proposed. A 3D image dataset of an examination region is recorded by a radiographic diagnostic device for generating a 3D vascular model. Contrast agent propagation in the examination region is captured by a dynamic 2D angiography method for generating a real 2D angiography recording. A CFD simulation of the blood flow is performed in the 3D vascular model based on a blood flow parameter for generating a virtual 2D angiography recording. A degree of correspondence between the real and the virtual 2D angiography recordings is determined from identical angulation and adjusted recording geometry of the patient and compared with predefinable tolerance values. The CFD simulation is iteratively optimized while changing the blood flow parameter as a function of the comparison. The degree of correspondence is outputted when the optimum CFD simulation is achieved."], "input": "CROSS REFERENCE TO RELATED APPLICATIONS \n     This application claims priority of German application No. 10 2010 039 312.6 filed Aug. 13, 2010, which is incorporated by reference herein in its entirety. \n     FIELD OF THE INVENTION \n     The invention relates to a method for simulating a blood flow in a vascular segment of a patient during angiography examinations. \n     BACKGROUND OF THE INVENTION \n     \u201cComputational Fluid Dynamics\u201d, also known as CFD for short, is a method for simulating the blood flow in a vascular section or vascular segment of a blood vessel which contains a pathological, i.e. a morbid change. Such a pathological change in the vascular section exists for example in the form of an aneurysm, i.e. a morbid, locally delimited, frequently bag-like enlargement. An aneurysm can occur in particular in a blood vessel in the region of the brain or of the heart; however, the occurrence of an aneurysm is generally not restricted to a specific region of the body. The clinical significance of an aneurysm, which for example is localized in the brain, arises in particular from the risk of a rupture, i.e. the formation of a tear or burst, which for example can result in hemorrhages and thromboses. In modern medicine, the dynamics of the blood flow in an aneurysm are frequently considered to be a major factor in the pathogenesis of the aneurysm, i.e. in its formation and development. \n     This simulation of the blood flow by CFD methods imparts a three-dimensional distribution of the flow parameters, such as for example WSS (Wall Shear Stress), along the surface of the vascular lumen. \n     DE 10 2008 014 792 B3 describes such a method for simulating a blood flow in a vascular section, wherein a captured image of a vascular region including the vascular section is obtained, a 3D vascular section model is determined from the captured image, a number of blood flow parameters are read in, the blood flow is simulated in the vascular section model with the inclusion of the or every blood flow parameter and a number of hemodynamic parameters are output. It is here provided that the captured image is obtained with an implant used in the vascular section such that image data of the implant is included, and that the 3D vascular section model is determined having regard to the image data of the implant used. Furthermore, a corresponding apparatus for simulating a blood flow in a vascular section is specified. \n     As is known from the article \u201cImage-Based Computational Simulation of Flow Dynamics in a Giant Intracranial Aneurysm\u201d by D. A. Steinmann et al. [1], a number of what are known as hemodynamic parameters are related to a growth and a burst of the aneurysm. A hemodynamic parameter is understood in particular as a parameter which relates to the hemodynamics, i.e. fluid mechanics, of the blood. In the cited article a pressure, a stress and shear stress affecting the vascular wall, as well as a flow rate, are mentioned among other things as hemodynamic parameters. In order to extrapolate such hemodynamic parameters, the blood flow in a vascular section which for example includes the aneurysm, is for example simulated. \n     In this article by D. A. Steinmann et al. [1] a 3D vascular section model is determined to this end from a 3D captured image which was obtained by means of rotational angiography. The blood flow in the 3D vascular section model is simulated using the CFD method. The simulation is performed here on the assumption of rigid vascular walls and a constant blood viscosity. CFD is a method of numeric flow simulation. The model equations used in numeric fluid mechanics are mostly based on a Navier-Stokes equation, on an Euler equation or on a potential equation. \n     This method of blood flow simulation is currently being employed in a number of experimental studies. A major restriction is that in this specific application on humans not all basic conditions necessary for the simulation are sufficiently precisely known on an individual patient basis. Hence it is difficult to validate the method and in the past this has not been done. \n     This means that the resulting flow results for the individual patient may be incorrect. Important basic conditions here include the geometry of the vascular section with aneurysm, the inflow and outflow values of the blood which change over time (speed, volume, etc.), the characteristics of the blood and the local elastic characteristics of the vascular wall. \n     To perform such rotational angiography to generate 3D captured images in order to obtain a 3D vascular section model, use is made of X-ray systems, the typical important features of which can for example be at least one C-arm, which can be robot-controlled and to which an X-ray tube and a radiographic image detector are attached, a patient support table, a high-voltage generator for generating the tube voltage, a system control unit and an imaging system including at least one monitor. \n     Such a typical X-ray system with a robot-mounted C-arm shown as an example in  FIG. 1  for example has a C-arm  2  rotatably mounted on a stand in the four of a six-axis industrial or buckling arm robot  1 , with an X-ray radiation source, for example a radiographic tube unit  3  with X-ray tube and collimator, and a radiographic image detector  4  as an image capturing unit being attached to the ends of said C-arm  2 . \n     In general CTA and MRA are also suitable for generating the 3D models. The advantage with C-arm systems is that if necessary the 2D recordings are intrinsically registered. Otherwise this has to be done for all modalities. \n     Using for example the buckling aim robot  1  known from U.S. Pat. No. 7,500,784 B2 which preferably has six rotary axes and thus six degrees of freedom, the C-arm  2  can be spatially readjusted at will, for example by being rotated about a center of rotation between the radiographic tube unit  3  and the radiographic image detector  4 . The inventive X-ray system  1  to  4  can in particular be rotated about centers of rotation and rotary axes in the C-arm plane of the radiographic image detector  4 , preferably about the center point of the radiographic image detector  4  and about rotary axes intersecting the center point of the radiographic image detector  4 . \n     The known buckling arm robot  1  has a base frame which for example is permanently mounted on a floor. Attached to this is a carrousel which can rotate about a first rotary axis. Fixed to the carrousel is a robot swing arm which can swivel about a second rotary axis, to which is attached a robot arm which can rotate about a third rotary axis. Fixed to the end of the robot arm is a robot hand which can rotate about a fourth rotary axis. The robot hand has a fixing element for the C-arm  2  which can swivel about a fifth rotary axis and can rotate about a sixth axis of rotation running perpendicular thereto. \n     The implementation of the radiographic diagnostic device is not reliant on the industrial robot. Standard C-arm devices can also be used. \n     The radiographic image detector  4  can be a rectangular or quadratic, flat semiconductor detector which is preferably made of amorphous silicon (a-Si). However, integrating and possibly metering CMOS detectors can also be used. \n     In the beam path of the radiographic tube unit  3  a patient  6  to be examined is placed on a patient support table  5  as an examination object for recording a heart for example. Connected to the radiographic diagnostic device is a system control unit  7  with an image system  8  which receives and processes the image signals from the radiographic image detector  4  (operating elements are for example not shown). The X-ray images can then be viewed on displays of a bank of monitors  9 . \n     In the methods currently used for blood flow simulation not all basic conditions necessary for the simulation are sufficiently precisely known on an individual patient basis in this specific application on humans. Hence it is difficult to validate the method. In the references cited below, different approaches are mentioned which enable CFD simulations to be validated. \n     In \u201cBlood flow in cerebral aneurysm: Comparison of phase contrast magnetic resonance and computational fluid dynamics\u2014preliminary results\u201d by Karmonik et al. [2] the result of a CFD simulation is compared to MR. The MR measurement itself is however imprecise because of the limited resolution and requires a considerable investment in time. Moreover this examination is virtually never performed on patients. \n     In \u201cMethodologies to assess blood flow in cerebral aneurysm: Current state of research and perspectives\u201d by Augsburger et al. [3] a procedure using in-vitro transparent vascular models and \u201cParticle Image Velocimetry\u201d (PIV) is described which permits CDF data to be compared to measured data. \n     However, neither method is suitable for validating the CFD measurement for the individual patient. \n     In \u201cQuantitative evaluation of virtual angiography for interventional X-ray acquisitions\u201d by Sun et al. [4] a method is described which is suitable for verifying CFD simulations for the individual patient in a particular way. To this end the CFD simulation is used to create a virtual angiography which can be compared to a genuine angiography recording of the patient. The result is a qualitative comparison in 2D. A description is additionally given of how to generate a center line and create a flow map along this center line in both angiography recordings. These two lines can be used to perform a quantitative comparison in 1D (along the line), which can be specified in the form of a relative mean quadratic error. \n     SUMMARY OF THE INVENTION \n     The object of the invention is to design a method for simulating a blood flow in a vascular segment of a patient during angiography examinations by a radiographic diagnostic device having a radiographic tube unit and a radiographic image detector, a patient support table and a system control unit, wherein a captured image of an examination region including the vascular segment is obtained, a 3D vascular model is determined from the captured image, a number of blood flow parameters are read in, and with the inclusion of these blood flow parameters the blood flow in the 3D vascular model is. The method enables the CFD simulation results to be validated for the individual patient, or any deviations to be quantitatively determined and used iteratively to improve the CFD simulation. \n     The object is inventively achieved for a method by the features specified in the independent claim. Advantageous embodiments are specified in the dependent claims. \n     The object is inventively achieved by the following steps:\n     a) Recording a 3D image dataset of an examination region including the vascular segment ( 20 ) for generating a 3D reconstruction image of the examination region,   b) Generating a 3D vascular model from the 3D image dataset,   c) Capturing a contrast agent propagation in the examination region by means of dynamic 2D angiography methods for generating real 2D angiography recordings,   d) Inputting at least one blood flow parameter,   e) Starting a CFD simulation of the blood flow in the 3D vascular model with the inclusion of the at least one blood flow parameter,   f) Generating virtual 2D angiography recordings from the results of the CFD simulation,   g) Determining a degree of correspondence between the real and the virtual 2D angiography recordings from identical angulation and adjusted recording geometry of the individual patient,   h) Comparing the degree of correspondence with predefinable tolerance values,   i) Iteratively optimizing the CFD simulation while changing the at least one blood flow parameter as a function of the comparison according to step h) and   j) Outputting the degree of correspondence (B i,j ) for the evaluation of the correspondence between the virtual and the real angiography.   \n\n     As a result information about the local blood flow, in and out of the vascular segment under consideration, can hereby be iteratively adjusted to the real 2D angiography recordings taken. \n     In fact a new dimension is introduced with the degree of correspondence. Even if other parameters are normally taken from the 2D angiography, these can currently only influence the CFD simulation if they are also used as simulation-relevant parameters. \n     The definition of the degree of correspondence and its iterative optimization is not reliant on extracting specific flow information from 2D angiography, since these parameters are very often defective. For some time attempts have been made to measure blood speeds in medical angiographies and to date no method is in use. Thanks to the comparison and the degree of correspondence any target parameters (e.g. contrast agent behavior at the highest point of the aneurysm), however abstract they are for the basic conditions for CFD simulation, can be employed for optimization. The aim is to optimize not the flow parameters (basic conditions or manipulated variables) used for the simulation, but the results of the CFD simulation. These must ultimately correspond to the real world. The person skilled in the art will ensure that no irrelevant conditions are obtained. \n     Advantageously the recording of a 3D image dataset of an examination region including the vascular segment can be obtained according to step a) by means of a radiographic diagnostic device with a radiographic tube unit and a radiographic image detector, a patient support table and a system control unit. \n     According to the invention a segmentation of the relevant vascular segment can be performed. \n     It has proved advantageous if the parameters for correcting each segment are selected individually if the vascular segment has several efferent vessels in which the correspondence in both outflowing vascular segments is different. \n     According to the invention the time intensity curves can be obtained for CFD simulation according to step e) from two scenes for each pixel or for a combination of several pixels, with at least one characteristic variable being extracted from said curves. \n     According to the invention, time values, intensity values and/or intensity values at defined times can be extracted as characteristic variables. \n     Advantageously the degree of correspondence according to step g) can be formed as follows:\n \n B   i,j   =T   i,j   \u2212T*   i,j  \n \nwith the degree of correspondence and the extracted variables for each pixel i,j from both angiographies.\n \n     According to the invention the degree of correspondence according to step g) can be a normalized degree of correspondence. \n     It has proved advantageous if the degree of correspondence according to step g) is determined for the bolus arrival times. \n     According to the invention the degree of correspondence according to step j) can be represented as an image and/or color-coded as a two-dimensional field. \n     Advantageously the 3D vascular model can be a 3D vascular section model or a 3D vascular surface model. \n     According to the invention, at least one of the following basic conditions can be input as blood flow parameters according to step d):\n         geometry of the vascular section with aneurysm,   inflow and outflow values of the blood, changing over time,   pressure at the inflow and outflow region,   blood characteristics and   local elastic characteristics of the vascular wall.       \n\n     It has proved to be advantageous if the pressure difference between inflow region and outflow regions, the flow rate and/or the blood volume are selected as a basic condition as inflow and outflow values of the blood, changing over time. \n    \n    \n     \n       BRIEF DESCRIPTION OF THE DRAWINGS \n       The invention is explained in greater detail below on the basis of the exemplary embodiments shown in the drawing: \n         FIG. 1  shows a known X-ray system with an industrial robot as a support apparatus for a C-arm, \n         FIG. 2  shows time intensity curves (TIC) with characteristic variables drawn in to explain the invention, \n         FIG. 3  shows an example of a vascular branching with aneurysm for defining ROIs and the associated basic conditions of flow Q and pressure P, \n         FIG. 4  shows a flowchart of an inventive method sequence and \n         FIG. 5  shows an inventive workflow. \n     \n    \n    \n     DETAILED DESCRIPTION OF THE INVENTION \n     In the inventive method, apparatus and workflow a degree of correspondence between a virtual angiography from a CFD simulation and a real angiography scene is determined and this degree of correspondence is used to purposefully and iteratively optimize the CFD simulation. \n     This degree of correspondence is based on the comparison between a virtual angiography and a real angiography from identical angulation and adjusted recording geometry of the individual patient. The inventive determination of the degree of correspondence in 2-D is an alternative approach to Sun et al. [4]. \n     Output data for this degree of correspondence is dynamic angiography scenes, which show the diffusion or passage of the contrast agent through the corresponding vascular system. The virtual dynamic angiography S* (the values indicated by * always relate in the following to the data derived from the virtual angiography) is obtained by means of CFD simulation. The time intensity curves TIC i,j  and TIC* i,j  are now obtained from these two scenes S and S* for each pixel (or combination of several pixels). \n     In the next step one or also more characteristic variables can be extracted from these time intensity curves, as described in \u201cParametric color coding of digital subtraction angiography\u201d by Strother et al. [5]. These can be time values and/or intensity values or intensity values at defined times. \n       FIG. 2  shows by way of example a time intensity curve (TIC) with drawn-in characteristic variables, in which the blood flow is plotted as intensity I over time t. After a noise-like behavior of the bolus curve  10  the intensity I climbs to the intensity maximum  11  (I max ), in order then to drop back to a noise level. The bolus curve  10  is furthermore characterized by its half-width  12  (FWHM\u2014Full Width at Half Maximum), which lies between the mean rise and the mean drop of the bolus curve. \n     The arrival time  13  (T rise ) is the time that elapses until the occurrence of the contrast agent bolus at the point under examination and thus until the rise in the bolus curve  10 . The mean rise time  14  (T rise, FWHM ) is the time that elapses until the occurrence of the half-width  12  of the bolus curve  10 , i.e. until the bolus curve  10  has reached half of the intensity maximum  11  (I max ). The time until the intensity maximum  11  (I max ) is called the maximum time  15  (T max ). The rise time  16  or wash-in time (T wash in ) characterizes the steep rise in the bolus curve  10 . The drop in the bolus curve  10  is characterized by the drop time  17  or wash-out time (t wash out ). The duration of the occurrence of the contrast agent bolus is characterized by the bolus or maximum time  18  (t Peak ). \n     In the following let T i,j  or T* i,j  be the extracted variable for each pixel i,j from both angiographies. \n     This produces a degree of correspondence B i,j  of both angiographies from a mathematical link between both values T i,j  or T* i,j , such as a simple subtraction for example.\n \n B   i,j   =T   i,j   \u2212T*   i,j  \n \n     This degree of correspondence is thus a two-dimensional field, which can be represented for example as an image (e.g. color-coded) and permits an evaluation of the correspondence between the virtual and the real angiography. \n     Theoretically this degree of correspondence can be determined as in Sun et al. [4] as a mean quadratic error for the entire curves TIC i,j  and TIC* i,j . However, this means it is then subsequently not possible to say anything about the nature of the deviation and thus it cannot be used for purposeful control of the CFD optimization. \n     Until now, however, the two angiography scenes have not been synchronized. In this application there are various excellent vascular regions in the angiography images, among which are the vascular regions into which the blood or the contrast agent flows. \n     In an improved embodiment regions of interest (ROI) in these vascular regions can be defined in both images. In this case one or more ROI, or corresponding ROI* in the virtual image can be selected such that they cover the vascular inflow regions. In a next step the mean value of the characteristic variable T i,j , or T* i,j  under consideration can be determined: MWT i,j , or MWT* i,j . From a comparison of these mean values a normalization is calculated in the following. This can be a difference (in the case of temporal values) or a factor e.g. in the case of intensity values, as well as other algorithms. \n     Thus the normalized degree of correspondence B i,j  of both angiography recordings can be balanced:\n \n B\u2032   i,j   =T   i,j   \u2212T*   i,j ( MWT   i,j   \u2212MWT*   i,j )\n \n     It is especially advantageous if the contrast inflow curve from the real angiography scene is used for the (initial) CFD simulation. \n     If the simulation of the virtual angiography is performed such that the virtual inflow of the contrast agent matches reality, a normalization can be dispensed with However, it can also happen that both curves are delayed in respect of one another at the time of inflow or have different grayscale values. In this case, depending on the question, normalization will bring an improvement. \n     Essential for the invention are the definition of a degree of correspondence and the use thereof to assess and optimize the CFD simulation individual to the patient which until now has not been possible in-vivo. In particular the missing information on the local flow, into and out of the vascular segment under consideration, can herewith be adjusted iteratively to the real recorded 2D angiography recordings. This results in an improvement in the CFD results. \n     This is based on the idea of comparing a virtual angiography obtained from the CFD simulation with the real angiography, determining a degree of correspondence, or if there is a difference optimizing the CFD so that the correspondence becomes better. \n     In the case of a patient a 3D subtraction angiography with a C-arm system of the cerebral vessels and one (or more) 2D subtraction angiography scenes are recorded. \n     In a first step a 3D surface model is generated in the computer following a segmentation of the relevant vascular section around an aneurysm, which is then used as geometry for the CFD simulation. Moreover inflow and outflow regions are established. \n       FIG. 3  shows a vascular segment  20  with an afferent vessel  21  as an example for the definition of the region of interest ROI and the associated basic conditions flow Q and pressure P, which vessel branches into a first efferent vessel  22  and a second efferent vessel  23 . The vascular segment  20  furthermore has an aneurysm  24 . The inlet to the afferent vessel  21  is formed by an inflow region  25 . The outlet of the first efferent vessel  22  is formed by a first outflow region  26  and the outlet of the second efferent vessel  23  by a second outflow region  27 . A flow Q in  (t) and a pressure P in  (t) prevail in the region of interest ROI in  of the inflow region  25 . In the region of interest ROI out1  of the first outflow region  26  a flow Q out1  (t) and a pressure P out1  (t) are measured and in the region of interest ROI out2  of the second outflow region  27  a flow Q out2  (t) and a pressure P out 2  (t) are measured. \n     The selected volume is adjusted here to the 2D angiography, i.e. an angulation and projection geometry corresponding to the 2D angiography are determined in the 3D angiography. If both recordings originate from an examination which involves no movement of the patient this is simple to calculate, but otherwise a registration must be performed. Thus the inflow region  25  and the outflow regions  26  and  27  are now also established in the 2D angiography. \n     In the following CFD simulation the propagation of an injected contrast agent is simulated, among other things. The temporal dynamics of the contrast agent inflow can be adjusted to the averaged time intensity curve from the 2D angiography. After the simulation a virtual 2D angiography is calculated by means of known angulation and projection geometry using forward projection (DRR), as is described for example in DE 10 2007 039 034 A1. \n     In a next step the normalized degree of correspondence B\u2032 i,j  e.g. for the bolus arrival times of both angiographies (real and virtual) is calculated. \n     If for example the typical vascular segment  20  with the afferent vessel  21 , the aneurysm  24  and the two efferent vessels  22  and  23  is considered, a further evaluation for control of an iterative CFD simulation can now take place. To this end the normalized degree of correspondence averaged in the ROI of the outflow regions  26  and  27  of the two efferent vessels  22  and  23  is considered. If it lies within a predefined tolerance, the result of the simulation is satisfactory in respect of these parameters, but otherwise this can be interpreted as a too fast or too slow flow in the entire vascular segment  20 . Physically this means that the basic condition of pressure difference between inflow region  25  and outflow regions  26  and  27  was selected suboptimally. This can happen, since the vascular resistance distally to the vascular arborization section under consideration is generally not known. \n     The tolerances can for example be predefined by a user. It is thereby determined how closely both angiographies, the virtual and the real angiography, must correspond before the user is satisfied. \n     If the normalized degree of correspondence is positive, the calculated flow is too low and in the subsequent CFD simulation the pressure difference or the pressure conditions must be increased at the outflow regions  26  and  27  (or variables corresponding thereto such as flow rate at the inflow region  25 ). In the case of a negative value the pressure difference can be reduced correspondingly. \n     If the correspondence in both outflowing vascular segments ROI out1  and ROI out 2  is different, this can be corrected individually for each segment by the individual selection of the parameters. \n     Another example of this is concerned with the vascular walls. In CFD simulations the vascular walls are increasingly treated elastically. A corresponding analysis can orient the regions of interest along the vascular walls. These are segmented to this end. The degree of correspondence is now determined locally for all pixels along the vascular wall and if values are too large the elasticity for the subsequent CFD simulation is adjusted. It is especially advantageous here if real angiographies from several angulations are present. \n     The inventive method is explained in greater detail on the basis of a flow chart shown in  FIG. 4 . First comes an acquisition  30  of a 3D angiography image dataset for model generation  31 . In the further method step a recording  32  of a contrast agent propagation is generated by means of dynamic real 2D angiography. Then a CFD simulation  33  is performed, wherein it is possible to input  34  blood flow parameters as basic conditions. A virtual 2D angiography  35  from angulation identical to the real angiography  32  and adjusted recording geometry of the individual patient is calculated from this data. Then follows a determination  36  of a degree of correspondence based on a comparison between the virtual angiography  35  and the real angiography  32  and then a check  37  to see whether the degree of correspondence is sufficient, i.e. whether the degree of correspondence is within a predefined tolerance. If the degree of correspondence is insufficient, a change  38  in the basic conditions in terms of an optimization is performed. Then follows a new optimized CFD simulation  38 , by means of which again a determination  36  is performed, followed by a check  37  on the degree of correspondence. If in contrast the degree of correspondence is sufficient, the degree of correspondence is output  40 , for example as a color-coded image and the end of the examination is initiated. \n     A (percentage) figure, if a global correspondence is considered, as well as a local figure can be described, which then itself can be output as a color map (degree of correspondence). However, it is also possible to describe other values (for example the time difference for the maximum grayscale values). \n       FIG. 5  shows the method sequence or workflow of the inventive method with the following steps in greater detail:\n     S 1 ) 3D imaging for model generation, e.g. by means of 3D rotational angiography.   S 2 ) Recording a contrast agent propagation by means of dynamic 2D angiography.   S 3 ) Initial CFD simulation and generation of a virtual 2D angiography.   S 4 ) Determining a degree of correspondence between real and virtual 2D angiography.   S 5 ) If degree of correspondence is sufficient, continue with S 9 ).   S 6 ) Changing one or more basic conditions of the CFD simulation according to the result of the degree of correspondence.   S 7 ) Renewed, optimized CFD simulation with basic conditions changed in terms of an optimization.   S 8 ) Back to S 4 ).   S 9 ) Done\u2014optimum CFD simulation was achieved.   \n\n     The result is an iterative optimization of CFD simulation results based on the comparison between real and virtual 2-DSA recordings on the basis of a determination of a degree of correspondence between both recordings. \n     REFERENCES \n     \n         \n         [1] Image-Based Computational Simulation of Flow Dynamics in a Giant Intracranial Aneurysm; David A. Steinman, Jaques S. Milner, Chris J. Norley, Stephen P. Lownie and David W. Holdsworth; American Journal of Neuroradiology (2003), Number 24, pages 559-566 \n         [2] Blood flow in cerebral aneurysm: Comparison of phase contrast magnetic resonance and computational fluid dynamics\u2014preliminary results; C. Karmonik, R. Klucznik, G. Benndorf; Fortschr R\u00f6ntgenstr 2008; 180:1-7 \n         [3] Methodologies to assess blood flow in cerebral aneurysm: Current state of research and perspectives; L. Augsburger, P. Reymond, E. Fonck, Z. Kulcsar, M. Farhat, M. Ohta, N. Stergiopulos, D. A. R\u00fcfenacht; J. Neurorad.-168: 2009; pages 1-8 \n         [4] Quantitative evaluation of virtual angiography for interventional X-ray acquisitions; Qi Sun, Alexandra Groth, Irina Waechter, Olivier Brina, J\u00fcrgen Weese, Til Aach; IEEE; 2009; pages 895-898 \n         [5] Parametric color coding of digital subtraction angiography; C. M. Strother, F. Bender, Y. Deuerling-Zheng, K. Royalty, K. A. Pulfer, J. Baumgart, M. Zellerhoff, B. Aagaard-Kienitz, D. B. Niemann, M. L. Lindstrom; AJNR Am J Neuroradiol; 2010; www.ajnr.org; pages 1-7", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["Provided are a method of cooking a raw meat and a plate of chicken prepared using the method. The plate of chicken is a healthy food and has a crispy coating and tender and moist inner flesh, like common fried chicken. The method of cooking a raw meat using oil contained therein includes: cutting the raw meat into pieces of a predetermined size and putting the cut raw meat pieces in a salt-containing sauce to age the raw meat pieces; removing the salt-containing sauce from the surface of the primarily aged raw meat pieces; putting the primarily aged raw meat pieces in an oven and roasting the raw meat pieces at a relatively low temperature such that juices come from the raw meat; uniformly coating the surface of each of the juicy raw meat pieces with coating powder; putting the raw meat pieces having the coating powder layer in an oven again and roasting the raw meat pieces; and further roasting the raw meat pieces, with the oven open, while supplying ambient air flow into the oven, such that having moisture vaporized from the coating powder layer of the raw meat pieces be exhausted out of the oven."], "input": "CROSS-REFERENCE TO RELATED PATENT APPLICATIONS \n       [0001]    This application claims the benefit of Korean Patent Application No. 10-2004-0054911, filed on Jul. 14, 2004, in the Korean Intellectual Property Office, the disclosure of which is incorporated herein in its entirety by reference. \n       BACKGROUND OF THE INVENTION \n       [0002]    1. Field of the Invention \n         [0003]    The present invention relates to a method of cooking meat, etc., and more particularly, to a method of cooking a meat, fowl, or seafood using oil contained therein, and a plate of chicken prepared using the method. \n         [0004]    2. Description of the Related Art \n         [0005]    In general, chicken can be cooked by, for example, frying in oil, boiling in water, direct roasting on a fire, etc. When frying chicken in cooking oil, the chicken can be coated with a paste or powder or with a paste and then powder. The surface of the fried chicken is crispy due to the powder or paste coated thereon, while the inner flesh part is tender and moist. Therefore, fried chicken has been one of the favorite foods of many people. \n         [0006]    However, since chicken is fried in high temperature oil, the fried chicken contains a large amount of oil and is greasy. In addition, due to the repeated use of oil in frying, the oil oxidizes, and cholesterol content increases. Moreover, due to high fat content and high calory content, the risk of diseases, such as obesity, heart disease, geriatric diseases, etc., increases for those who eat fried chicken. Therefore, eating such fried chicken fried directly in oil conflicts with the recently wide-spread health trend of modern people who value a healthy diet. Accordingly, despite a large variety of nutrients in chicken and the excellent taste of fried chicken, many people hesitate to eat fried chicken. \n       SUMMARY OF THE INVENTION \n       [0007]    The present invention provides a method of cooking raw meat, such as meat, fowl, or fish, using oil contained therein to lower fat, calory, and cholesterol contents. The present invention also provides a plate of chicken prepared using the above method, the plate of chicken having low fat, calory, and cholesterol contents. The plate of chicken according to the present invention is a healthy food and has a crispy coating and tender and moist inner flesh, like common fried chicken. \n         [0008]    According to an aspect of the present invention, there is provided a method of cooking a raw meat using oil contained in the raw meat, the method comprising: cutting the raw meat into pieces of a predetermined size and putting the cut raw meat pieces in a salt-containing sauce to primarily age the raw meat pieces for a predetermined time; removing the salt-containing sauce from the surface of the primarily aged raw meat pieces and uniformly coating the surface of each of the raw meat pieces with coating powder; maintaining the raw meat pieces coated with the coating powder at an ambient temperature for a predetermined time to secondarily age the raw meat pieces such that the coating powder absorbs moisture in the raw meat pieces and forms a coating powder layer; putting the secondarily aged raw meat pieces in an oven and roasting the raw meat pieces at a temperature of 130\u02dc270\u00b0 C. for 7\u02dc20 minutes; and further roasting the raw meat pieces at a temperature of 130\u02dc270\u00b0 C. for 2\u02dc5 minutes while supplying an air flow to the oven. \n         [0009]    The salt-containing sauce may be a marinade containing refined salt, soy sauce, pepper powder, white sugar, and onion juice as main components, and the primary aging is performed for 24\u02dc48 hours. \n         [0010]    The coating powder may be prepared by mixing 76.34\u02dc81.11% by weight of wheat flour, 5.79\u02dc9.54% by weight of corn starch, 5.73\u02dc5.79% by weight of refined salt, 5.21\u02dc5.25% by weight of L-sodium glutamate, 1.16\u02dc1.43% by weight of red pepper powder, 0.58\u02dc0.95 by weight of black pepper powder, and 0.35\u02dc0.76% by weight of garlic powder. \n         [0011]    The raw meat may be selected from the group consisting of meats, such as pork, beef, etc., fowls, such as chicken, duck, goose, turkey, etc., and seafoods, such as lobster, shrimp, shellfish, and fishes. \n         [0012]    When the raw meat is a high fat content meat, such as pork, the coating powder may further include bread crumbles. \n         [0013]    According to another aspect of the present invention, there is provided a plate of chicken prepared using the above-described method. \n     \n    \n     DETAILED DESCRIPTION OF THE INVENTION \n       [0014]    Hereinafter, embodiments of the present invention will be described in detail. \n         [0015]    A cooking method according to the present invention includes two aging processes performed under different conditions and two roasting processes. \n         [0016]    In particular, a raw meat is cut into pieces, each having an average diameter of 4\u02dc10 cm and a weight of 70\u02dc150 g and put in a salt-containing sauce for primary aging. The salt-containing sauce is a marinade containing refined salt, soy sauce, pepper powder, white sugar, and onion juice as main components. The aging time may be in a range of 24\u02dc48 hours. The spices soak into the raw meat through the aging process. \n         [0017]    Next, the surface of each of the raw meat pieces is coated with coating powder. When it is necessary to relieve the salty taste of the meat, the salt-containing sauce can be removed from the surface of the raw meat pieces before it is coated with coating powder. The coating powder is prepared by adding seasonings, such as refined salt, monosodium L-glutamate, red pepper powder, black pepper powder, garlic powder, etc., into wheat flour or corn starch, which are main components. An appropriate mixing ratio of seasonings in the coating powder is shown in Table 1. An optimal mixing ratio of seasonings in coating powder determined through several times of test cooking is shown in Table 2. A hot seasoning may be further added to emphasize the hot taste. \n         [0000]    \n       \n         \n               \n               \n               \n             \n           \n               \n                   \n                 TABLE 1 \n               \n               \n                   \n                   \n               \n               \n                   \n                   \n                 Appropriate ratio \n               \n               \n                   \n                 Ingredient \n                 (% by weight) \n               \n               \n                   \n                   \n               \n             \n             \n               \n                   \n                 Wheat flour \n                 76.34~81.11 \n               \n               \n                   \n                 Corn starch \n                 5.79~9.54 \n               \n               \n                   \n                 Refined salt \n                 5.73~5.79 \n               \n               \n                   \n                 Monosodium L-glutamate \n                 5.21~5.25 \n               \n               \n                   \n                 Red pepper powder \n                 1.16~1.43 \n               \n               \n                   \n                 Black pepper powder \n                 0.58~0.95 \n               \n               \n                   \n                 Garlic powder \n                 0.35~0.76 \n               \n               \n                   \n                   \n               \n             \n          \n         \n       \n     \n         [0000]    \n       \n         \n               \n               \n               \n             \n               \n               \n               \n             \n           \n               \n                   \n                 TABLE 2 \n               \n               \n                   \n                   \n               \n               \n                   \n                   \n                 Optimal ratio \n               \n               \n                   \n                 Ingredient \n                 (% by weight) \n               \n               \n                   \n                   \n               \n             \n             \n               \n                   \n               \n             \n          \n           \n               \n                   \n                 Wheat flour \n                 78.95 \n               \n               \n                   \n                 Corn starch \n                 7.37 \n               \n               \n                   \n                 Refined salt \n                 5.79 \n               \n               \n                   \n                 Monosodium L-glutamate \n                 5.26 \n               \n               \n                   \n                 Red pepper powder \n                 1.26 \n               \n               \n                   \n                 Black pepper powder \n                 0.84 \n               \n               \n                   \n                 Garlic powder \n                 0.53 \n               \n               \n                   \n                   \n               \n             \n          \n         \n       \n     \n         [0018]    Next, the raw meat pieces coated with the coating powder is subjected to secondary aging for a predetermined time to allow the coating powder on the surface of the raw meat to absorb moisture in the raw meat and form a coating powder layer. \n         [0019]    In this secondary aging process, the raw meat pieces on which the coating powder has been coated are maintained in a dark refrigeration space at a temperature of \u22122.0\u02dc10.0\u00b0 C. for 1\u02dc2 hours. \n         [0020]    Alternatively, if necessary to cook quickly, instead of waiting for the coating powder layer to be formed by absorbing moisture in the raw meat, the coating power layer can be formed by spraying water on the coating power of the surface of the raw meat. However, for more crispy taste of the surface of the meat prepared according to present invention, it is better to wait for the coating powder layer to be formed by absorbing moisture in the raw meat through the secondary aging process. \n         [0021]    Next, the secondarily aged raw meat pieces are roasted in an oven in a closed state at a temperature of 130\u02dc270\u00b0 C. for 7\u02dc20 minutes. Any type of cooking device, such as a gas oven, an electric oven, etc., can be used provided that it has a closed space for heating. However, cooking devices using radiation heat or convection heat are preferred to cooking devices using heat conduction, like frying fans. In the cooking method according to the present invention, cooking devices using radiation heat or convection heat are suitable to uniformly heat the aged raw meat pieces of a predetermined size. \n         [0022]    Next, the raw meat pieces are further roasted at a temperature of 130\u02dc270\u00b0 C. for 2\u02dc5 minutes while supplying an air flow to the oven. In this process, air is flowed into the oven to evaporate moisture from the surface of the coating powder layer of the meat and exhaust the moisture out of the oven. This process facilitates the evaporation of moisture from the surface of the meat. \n         [0023]    If air is flowed throughout the entire roasting operation, i.e., from the beginning to the end of the roasting operation, or if the duration of roasting the meat while supplying an air flow is longer than 5 minutes, too much moisture in the meat is evaporated and the meat texture becomes too tough or chewy. If the duration of roasting the meat while supplying an air flow is shorter than 2 minutes, a proper amount of moisture cannot be evaporated from the coating powder layer and the roasted meat is not crispy. The roasting time ranging from 2\u02dc5 minutes can be varied according to the water content of the raw meat. \n         [0024]    The surface of the meat roasted through the above-described processes looks very similar to common fried chicken. In addition, the surface of the roasted meat is crispy while the inner flesh is tender and moist. \n         [0025]    Although the surface of the meat cooked according to the present invention looks very similar to common fried chicken, the meat cooked according to the present invention has very different composition from the common fried chicken. In particular, since the coating powder layer on the meat is fried by oil contained in the meat through two roasting processes, its fat and cholesterol contents are markedly lower than those of common fried chicken, which is fried in cooking oil. In addition, since the oil in the meat comes out, the inner flesh becomes non-greasy, soft, and less tough. \n         [0026]    In conventional methods of cooking by frying, due to the repeated use of frying oil and the oxidization of the oil, cholesterol content increases. In addition, it is highly likely that foreign substance is incorporated into the oil during storage, and small fragments of previously fried foods remain, raising a hygienic problem. However, in the cooking method according to the present invention, such problems do not arise, and low fat, cholesterol, and calory food can be hygienically cooked. \n         [0027]    The two roasting processes in the cooking method according to the present invention may be performed in reverse order. In other words, the roasting process performed while supplying an air flow can be performed first. However, to accelerate the evaporation of moisture to obtain cooked meat with a crispy surface coating, it is preferable to perform the roasting process while supplying an air flow secondly. \n         [0028]    Any kind of raw meat can be cooked using the above-described cooking method according to the present invention. Examples of raw meat that can be cooked according to the present invention include: meats, such as pork, beef, etc.; fowls, such as chicken, duck, goose, turkey, etc.; seafoods, such as lobster, shrimp, shellfish, fishes, etc. For a high fat content raw meat, such as pork, bread crumbles may be added to the coating powder such that a larger amount of the oily component in the raw meat can be absorbed. As a result, a less greasy, tender, and moist cooked meat with a crispy coating can be obtained. \n         [0029]    As described above, in a cooking method according to the present invention, instead of frying a raw meat in boil, after coating the raw meat with a coating powder layer, the raw meat is roasted using oil contained in the raw meat while supplying an air flow for a predetermined duration to evaporate moisture in the meat and increase crispiness of the surface of the meat. The obtained cooked meat has low fat content and is not greasy. In addition, the surface coating of the cooked meat is crispy while the inner flesh thereof is tender and moist. \n         [0030]    In a nutritional aspect, using the cooking method according to the present invention, which does not involve frying in oil, low calory, fat, and cholesterol foods can be cooked, which complies with the currently spread healthy diet trend. \n         [0031]    In particular, when the cooking method according to the present invention is used to cook chicken, low calory, fat, and cholesterol, healthy cooked chicken, which is very similar to popular fried chicken, can be obtained. \n         [0032]    According to the present invention, a plate of chicken that has low Trans fatty acid content and is good for health can be prepared. Trans fatty acids in diet, which are generated as a result of partial hydrogenation of vegetable oils, have been implicated to cause or exacerbate most modern diseases, including heart disease, cancer, diabetes, obesity, immune dysfunction, and bone loss. The major form of Trans fatty acid included in milk, dairy products, meat etc. is Vaccenic acid (trans-11, 18:1). Table 3 shows the contents of Vaccenic acid (trans-11, 18:1) in the skin of chicken prepared to be served to a customer. The content of Vaccenic acid (trans-11, 18:1) in the skin of the plate of chicken prepared according to the method of present invention was about 4.25%. However, in the case of Comparative Example 1 (fried chicken cooked by frying in oil, Company A), the content of Vaccenic acid (trans-11, 18:1) was about 12.94%. In the case of Comparative Example 2 (fried chicken cooked by frying in oil, Company B), the content of Vaccenic acid (trans-11, 18:1) was about 6.12%. \n         [0000]    \n       \n         \n               \n               \n               \n               \n             \n           \n               \n                 TABLE 3 \n               \n               \n                   \n               \n               \n                   \n                   \n                 Comparative \n                 Comparative \n               \n               \n                 Fatty acid \n                 Present invention \n                 Example 1 \n                 Example 2 \n               \n               \n                   \n               \n             \n             \n               \n                 Vaccenic acid \n                 4.25% \n                 12.94% \n                 6.12% \n               \n               \n                 (trans-11, 18:1) \n               \n               \n                   \n               \n             \n          \n         \n       \n     \n         [0033]    A cooking method according to another embodiment of the present invention is the same, from cutting raw meat into pieces to aging the raw meat pieces with a salt-containing sauce, as the embodiment described above. \n         [0034]    When the aging process is completed, primary roasting is performed. In primary roasting, the raw meat pieces are cooked to an extent of about 30% to about 70% using steam or oven heat. \n         [0035]    For example, the raw meat pieces may be primarily roasted using a far-infrared radiation oven. When a far-infrared radiation oven is used, the temperature of a far-infrared bulb may be maintained at about 300\u00b0 C. to about 550\u00b0 C. In this case, the surface temperature of the raw meat pieces is maintained at about 30\u00b0 C. to about 80\u00b0 C. for about 10 to about 20 minutes. \n         [0036]    The primary roasting process sterilizes the raw meat pieces to some extent and removes oil from the raw meat pieces. In addition, water contained in surface regions of the raw meat pieces is partially evaporated. In the primary roasting operation, the water content of the raw meat pieces may be reduced to about 10.0 wt % to about 15.0 wt %. If the water content is less than 10.0 wt %, crispness of the surface of a coating powder layer of cooked meat may be reduced. On the other hand, if the water content is more than 15.0 wt %, the cooked meat may become tough. \n         [0037]    Next, a coating powder layer is formed. The oil removed from surface regions of the raw meat pieces in the primary roasting operation enables coating powder to easily adhere the surface of the raw meat pieces, and thus forms the coating powder layer. \n         [0038]    Examples of the coating powder are the same as described in the previous embodiment. In addition, the composition of the coating powder is not limited to the compositions suggested in Tables 1 and 2 above. For example, wheat flour or corn starch may be partially or wholly substituted with one component selected from the group consisting of rice flour, barley flour, soybean flour, potato starch and sweet potato starch. \n         [0039]    Next, secondary roasting is performed to finish cooking the raw meat pieces. The secondary roasting operation includes preheating a roasting utensil and placing and heating the raw meat pieces in the preheated roasting utensil. \n         [0040]    In the secondary roasting operation, the heating temperature may be in a range of about 130\u00b0 C. to about 270\u00b0 C., and the heating time may be in a range of about 9 to about 25 minutes. The roasting utensil may include any type of cooking device for roasting in a closed environment, such as a gas oven, an electric oven, etc. For example, the roasting utensil may include heating wires in upper and lower racks where the raw meat pieces are to be placed so that the top and bottom surfaces of the raw meat pieces can be heated. \n         [0041]    In the secondary roasting operation, air may be made flow into the roasting utensil for about 2 to about 5 minutes. Air flowing into the oven exhausts water vapor out of the roasting utensil, and thus facilitates the evaporation of water from the surfaces of the raw meat pieces. \n         [0042]    If air is made to flow throughout the entire roasting operation, i.e., from the beginning to the end of the roasting operation, or if the duration of roasting the raw meat pieces while supplying an air flow is longer than 5 minutes, too much moisture in the raw meat pieces is evaporated and the meat texture becomes too tough or chewy. If the duration of roasting the raw meat pieces while supplying an air flow is shorter than 2 minutes, a proper amount of moisture cannot be evaporated from the coating powder layer and the roasted meat is not crispy. The roasting time ranging from about 2 to about 5 minutes may be varied according to the water content of the raw meat. \n         [0043]    The surface of the meat roasted by performing the above-described processes looks very similar to common fried chicken. In addition, the surface of the roasted meat is crispy while the inner flesh is tender, non-greasy and moist. \n         [0044]    Although the surface of the meat cooked according to the present invention looks very similar to common fried chicken, the meat cooked according to the present invention has a very different composition from common fried chicken. In particular, since the coating powder layer on the meat is fried by oil contained in the meat through two roasting processes, its fat and cholesterol contents are markedly lower than those of common fried chicken, which is fried in cooking oil. In addition, since the oil in the meat is removed, the inner flesh becomes non-greasy, soft, and less tough. \n         [0045]    In conventional methods of cooking by frying, due to the repeated use of frying oil, it is highly likely that foreign substances are incorporated into the oil during storage, and small fragments of previously fried foods remain, raising a hygienic problem. However, in the cooking method according to the present invention, such problems do not arise, and low fat, and low calorie food can be hygienically cooked. \n         [0046]    While the present invention has been particularly shown and described with reference to embodiments thereof, the embodiments are for only descriptive purposes and are not intended to limit the scope of the invention. The scope of the invention is defined only by the appended claims. It will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope of the present invention as defined by the following claims.", "source": "patent_summ", "evaluation": "rouge"}
{"instructions": ["You are a patent examiner. Please write a summary of this patent."], "outputs": ["The invention provides a method and system for cleaning pet paws providing a bounded container containing a plurality of soft scrub brushes defining a paw cleaning region within an outer container wall wherein cleaning solution can flow freely within the container between a paw-for-cleaning, the container wall, and the brushes while allowing space for sediment. A spill resistant lid allows easy transport. An optional splash resistant lid containing a further brush boundary enables an enhanced side leg cleaning. The proposed method and system enables an enhanced deep cleaning through repeated submersion within the container and removable of debris. The system aids in prevention of infection and disease."], "input": "CROSS REFERENCE TO RELATED APPLICATIONS \n       [0001]    This application relates to and claims priority from U.S. Ser. No. 61/819,547 filed May 4, 2013, the entire contents of which are incorporated herein by reference. \n     \n    \n     FIGURE FOR PUBLICATION \n       [0002]    \n       FIG. 1 \n     \n       BACKGROUND OF THE INVENTION \n       [0003]    1. Field of the Invention \n         [0004]    The present invention relates to a method and system for cleaning pet paws or other animal appendages including feet, hooves, ears, tails, and limbs. More particularly, the present invention provides a method and system for cleaning pet appendages that is readily transported and stored between uses, readily adapts to specific uses, and enables rapid and effective appendage cleaning but may be readily cleaned and sealed between uses. \n         [0005]    2. Description of the Related Art \n         [0006]    Conventional pet foot cleaning devices are generally known from simple washings in a tub or basin using soapy water and optionally with the use of hand-agitation. Over time more complex, and expensive, devices have been developed. \n         [0007]    One such complex device is a grooming and cleaning scissor action device using a pair of opposed semi-circular brushes, as seen in U.S. Pat. No. 7,258,078 (Maiello), the contents of which are incorporated herein by reference. In use, the brushes are placed about a base of an animal tail, limb, or paw, and squeezed together applying pressure to the animal appendage. It is envisioned, that in cleaning such an animal would be outside, or standing in a tub able to receive any removed debris. Unfortunately, there is no ability to transport the cleaning device convenient with cleaning solution, and the device is not convenient to all forms of appendage. In use, the device is more for show-grooming to fluff-hair than for real cleaning. The device cannot be easily transported post-use or sterilized. \n         [0008]    Another difficult device is a paw sucker as shown in U.S. Pat. No. 7,654,228 (Graham), the entire contents of which are incorporated herein by reference, where an extensive spray and suction device (operating with a suction motor) is placed about a paw and agitated. A complex discharge hose and separate waste canister are employed requiring extensive costs and difficulty. \n         [0009]    A different product tube is provided with a splash guard in U.S. Pat. No. 8,371,247 (Flemming), the entire contents of which are incorporated herein by reference, wherein a sort of elastic sock is placed about a curved frustoconical tube. During use, an animals foot is thrust within, but lacking any retaining or sealing feature, the sock is readily released from the tube and be retained on a paw or foot, easily spilling any solution in the frustoconical tube, and being otherwise non-usable for transport and easy steralization. \n         [0010]    In an unrelated human pre-operative surgical cleaning device U.S. Pat. No. 4,181,446 (Kaufman), the entire contents of which are incorporated herein by reference, a flexible surgical scrubber brush is provided that has bristles on one side and a rubbing pad or sponge on a back side thereof. In cleaning a human patient or medical device, extensive user-hand manipulation bends and flexes the brush and forces the bristles of the brush into finger joints. \n       ASPECTS AND SUMMARY OF THE INVENTION \n       [0011]    In response, it is now recognized that there is a need for an improved paw cleaning method and system that addresses at least one of the concerns noted. \n         [0012]    In another aspect of the present invention, there is a method and system provided to reduce or eliminate the transmission of bacteria, parasites, fungus, toxins, contaminants, irritants, chemicals, and waste products found on roads, sidewalks, parks into user&#39;s homes, automobiles, or other locations where cleanliness is desired. \n         [0013]    In one aspect of the present invention, there is provided a method and system for cleaning pet limbs, particularly feet, providing a bounded container containing a plurality of soft scrub brushes defining a paw cleaning region within an outer container wall wherein cleaning solution can flow freely within the container between a paw-for-cleaning, the container wall, and the brushes while allowing space for sediment. \n         [0014]    Another alternative aspect of the present invention provides a sealing spill resistant lid for sealing the container between uses for easy transport and containing any fresh cleaning solution, or transporting any post-cleaning debris prior to disposal. \n         [0015]    In another alternative aspect of the present invention a splash resistant lid contains a further brush boundary feature enabling an enhanced side limb or leg cleaning during use. \n         [0016]    In another alternative aspect of the present invention, the proposed method and system enables an enhanced deep cleaning through repeated submersion within the container and removable of debris. The system aids in prevention of infection and disease. \n         [0017]    It is another alternative aspect of the present invention, wherein, the brush elements may be provided in a fixed form or in an optional removable-replaceable form. For example, a separate removable brush-holding cradle, or even a removable brush, may be used or slots or retainer structures may be formed directly into the container wall to removable-receive brushes or a brush-holding cradle. The brushes, in such brush-holding cradle or the slots or retaining structures, may be recycled (but cleaned or not yet used) brushes. Such brushes may be sourced, for example, from the surgical procedure brushes (approximately 1-5 million used annually) many of which are \u2018used\u2019 in a medial sense (not sterile) and must be discarded for safety, but which are fully-clean and ready for use in a practical animal-cleaning process. For example, a brush package (noted below) may be opened-for-surgical-use, but never actually used\u2014such a brush is fully clean but cannot be re-packaged and must be thrown away, and could be recycled for use in the present invention. In another example, such brushes may have an \u2018expiration\u2019 or \u2018use by\u2019 date on such packaging when made in mass, and non-use prior to the date prevents use on a human patient. The present invention promotes recycling by providing a system to use such devices. \n         [0018]    The above and other aspects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawings, in which like reference numerals designate the same elements. \n     \n    \n     \n       BRIEF DESCRIPTION OF THE DRAWINGS \n         [0019]      FIG. 1A  is an illustrative view of the proposed system relative to a paw to be cleaned. \n           [0020]      FIG. 1B  is an illustrative view of the proposed system with a paw inserted for cleaning. \n           [0021]      FIG. 2  is a perspective view of the proposed system with a cleaning cover installed for use. \n           [0022]      FIG. 3  is an exploded view of  FIG. 2  with an alternative sealing lid optionally provided for the container. \n           [0023]      FIG. 4  is a sectional view along Section  4 - 4  in  FIG. 2 . \n           [0024]      FIG. 4A  is a sectional view along section  4 A- 4 A in  FIG. 4 . \n           [0025]      FIG. 5  is a top plan view of an alternative sectional through a container as in  FIG. 1A , shown with three brush elements. \n           [0026]      FIG. 6  is a top plan view of another alternative section through a container as shown in  FIG. 1A , shown with five brush elements. \n       \n    \n    \n     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS \n       [0027]    Reference will now be made in detail to embodiments of the invention. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps. The drawings are in simplified form and are not to precise scale. The word \u2018couple\u2019 and similar terms do not necessarily denote direct and immediate connections, but also include connections through intermediate elements or devices. For purposes of convenience and clarity only, directional (up/down, etc.) or motional (forward/back, etc.) terms may be used with respect to the drawings. These and similar directional terms should not be construed to limit the scope in any manner. It will also be understood that other embodiments may be utilized without departing from the scope of the present invention, and that the detailed description is not to be taken in a limiting sense, and that elements may be differently positioned, or otherwise noted as in the appended claims without requirements of the written description being required thereto. \n         [0028]    Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments of the present invention; however, the order of description should not be construed to imply that these operations are order dependent. \n         [0029]    Referring now to  FIGS. 1A and 1B , a proposed cleaning system  1  is provided with a container  2  for retaining, and optionally removably retaining one or more brushes  8  relative to an animal limb  5  (a paw is shown) to be cleaned. Container  2  includes threads  7  about an outer upper surface thereof for removable engagement with a cleaning cover  3 , or a sealing lid or cover  4 , as will be discussed. During a use, limb  5  is thrust within container  2  and agitated with bristles  8 B of brushes  8  for removal of debris and detritus. Additional solutions may be added, including water, detergent, and other types, without departing from the scope and sprit of the present invention. \n         [0030]    Additionally referring now to  FIGS. 2 and 3 , wherein system  1  is provided with a threadably secured cleaning cover  3  having a cleaning opening  3 A for receiving limb  5  therein. As shown in  FIGS. 2 and 3 , the inner surface of cleaning opening  3 A additionally contains a brush element  8  with bristles  8 B facing inwardly. Additionally, in  FIG. 3 , sealing lid  4  is provided having an interior threading section  7  (as shown) which may threadably engage an additional outer threaded section on the outer surface of cleaning lid  3 , see  FIG. 3  for this version. As will be appreciated in  FIG. 3 , an entire system  1  may be modified to have, in combination container  2 , cleaning lid  3 , and sealing lid  4 , or (as shown in  FIG. 2 ) system  1  may including container  2  and cleaning lid  3 , without a cover. \n         [0031]    In either case, cleaning cover  3  may be readily modified to have threads  7 , on an inner or outer surface, or both, without departing from the scope and spirit of the present invention. Additionally, it will be noted that threads  7  may be replaced with sealing tabs (not shown) sealing frictio-rings (like a sealing lid), or any other type of engagement system to secure cover  3  or lid  4  to container  2 , without departing from the scope and spirit of the present invention. \n         [0032]    Additionally referring now to  FIGS. 4 and 4A , wherein a cross section and top-section view are provided of a system  1 , engaged and containing solution  6 , which may be any suitable fluid component, or combination of components for washing, sterilizing, etc. and may contain antimicrobial, antibiotic, anti-fungal, or other curative and assistive components, and solutions within the scope of the present invention. For example, medical treatment components may be added to solution  6 . \n         [0033]    As will be appreciated each brush  8  contains a brush base SA that spaces the respective brush  8 , having bristles  8 B from the outer container  2 . Base  8 A contains flow openings  8 C both on a side leg region and a base region supporting bristles  8 B. It will therefore be recognized by those of skill in the art having studied the present invention, that solution  6  may flow readily between bristles  8 B, base  8 A, flow holes  8 C and brush  8  during a use, and may slosh throughout system  1  to aid in treating, cleaning, rinsing, or contacting an animal limb  5  during a use. See for example the flow arrows noted in  FIGS. 4 and 4A . It will also be understood, that solution  6  may be of any level in system  1 . It will also be understood that any debris or detritus removed from an animal limb  5  during use, may remain within container  2  post-use, so as to allow for easy removal and rinsing-out by removal of cleaning cover  3 . \n         [0034]    It will additionally be understood, that the proposed system  1  may function suitably without a cleaning cover  3  (as is shown in  FIGS. 1A ,  1 B. For example, where an especially large animal limb  5  is used, cover  3  may be unduly restricting, and may be removed. \n         [0035]    Referring now to  FIGS. 5 and 6 , it will be noted that instead of a roundish, brush  8  (central brush  8  shown in  FIGS. 2-4A , several component member brushes  8  may be used for similar effects without departing from the scope and spirit of the present invention. For example, as seen in  FIG. 5 , four brushes  8  may be arranged (one on the bottom and three in triangle form). For another example, as seen in  FIG. 6 , six brushes  8  may be arranged (one on the bottom and five in pentagon form). In the examples in  FIGS. 5 and 6 , it will be understood, that a plurality of brushes  8 , or a continuous brush  8 , may be used without departing from the scope and spirit of the present invention. \n         [0036]    In an alternative embodiment regarding  FIGS. 2 and 3 , it will be understood that side and bottom brushes  8  maybe formed as a single integral unit, that is slidably removable from within container  2  without departing from the scope and spirit of the present invention. For example, a unitary replacement brush unit (not shown) may be slidable removable in and out of container  2  within the scope of the present invention. Additionally, a further example would involve a brush-carrier unit (not shown), wherein a plurality individual brushes  8  (linear, arc shaped or otherwise) may be removably retained in a brush-carrier unit (not shown) that is slid within container  2  for holding replacement brushes. \n         [0037]    In one aspect of the present invention, surgical scrub brushes are employed in the container and cleaning lid derived from Scrub Care\u00ae which is a surgical scrub brush-sponge/nail cleaning mixed with Exidine\u00ae4 a type of germicidal solution; Allegiance Heathcare Corporation, McGaw Park, Ill. 60085 US, (NDC 63517-007-25). In this use, the surgical brushes are constructed from a suitable plastic (polyethylene (PE), high density PE (HDPE), medium density PE (MDPE), low density PE (LDPE), or any other type of plastic suitable for the purposes intended. Additionally, the brushes are not limited to plastic, but may be constructed from suitable natural materials, including but not limited to, fibers, hair, bristles, and any other type of natural brush-like fiber that would be suitable for the purposes intended. Additionally, a brush may be constructed from a combination of materials without departing from the scope and spirit of the present invention. For example, a brush backing may be of plastic and bristles may be boar-hair or other natural material, and vice-versa. \n         [0038]    It is another alternative aspect of the present invention, that a the brush construction/bristle construction shown within the container may be formed in alternative shapes without departing from the scope and spirit of the present invention. For example, a continuous bounding surface of bristles may be provided (e.g., a circular bristle surface), or any other related shape. Additionally, a brush may be removed from a floor/bottom surface of the container as a modification thereof. Additionally, a brush-holding cradle may be inserted into the container, so that the brush-holding cradle may be removed from the container (the brushes not being fixed to the container wall, but fixed to a brush-holding cradle (noted but not shown). As a result, it will be apparent to those of skill in the art having studied the present disclosure that the method and system may be modified without departing from the scope and spirit of the present invention. \n         [0039]    It will also be understood, that as used herein the device may be used with any cleaning solution, soap, detergent, germicidal or antiseptic for dispersion or surface scrubbing known within the surgical or veterinarian arts without departing from the scope and spirit of the present invention. \n         [0040]    It will be understood that the present invention relates to a method and system for cleaning pet paws or other animal appendages including feet, hooves, and limbs. It will be understood that a dog-paw may be conveniently used, but also conveniently a sheep hoof may be cleaned, or a rabbit foot\u2014all with differing shapes and needs for cleaning, but all ready cleaned by adaptive us of the present device. Therefore, it will be recognized by one of skill in the art having studied the present disclosure, that the present device using a plurality of flow-through type brushes may be easily used to clean a range of animals. For example, cleaning sheep hooves for serious medical treatment or disease prevention or cleaning a pet-dog foot following a simple walk during a winter or muddy day. More particularly, the present invention provides a method and system for cleaning pet appendages that is readily transported and stored between uses, readily adapts to specific uses, and environments proximate that treatment surface is not limited. \n         [0041]    Having described at least one of the preferred embodiments of the present invention with reference to the accompanying drawings, it will be apparent to those skills that the invention is not limited to those precise embodiments, and that various modifications and variations can be made in the presently disclosed system without departing from the scope or spirit of the invention. Thus, it is intended that the present disclosure cover modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.", "source": "patent_summ", "evaluation": "LLM"}
